NCT06194864 - Drug Interaction Study | Crick | Crick

Drug Interaction Study

Phase 1CompletedNCT06194864

Emalex Biosciences Inc.45 enrolled

Overview

This is a single center, 2-Part, Phase 1, open-label, fixed-sequence, drug-drug interaction study designed to compare the PK of ecopipam when administered alone and in combination with itraconazole (Part 1) or rifampicin (Part 2) in healthy subjects.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

45

Conditions

Drug Interaction

Interventions

ItraconazoleDRUG

itraconazole 200 mg QD Days 6 to 16

rifampicin 600 mg QD Days 6 to 20

89.6 mg on Days 1 and 9 for Part 1 or 179.2 mg on Days 1 and 13 for Part 2

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male subjects or femail subjects of non-childbearing potential * ≥18 and ≤55 years of age * BMI \>18.5 and \<30.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females. * Subjects must be healthy, as determined by the Investigator, based on medical history, physical examination, ECG, vital signs, and standard panel of blood and laboratory tests at Screening. * Sexually active males must use a double barrier method of contraception during the study and for at least 90 days after the last dose of study drug. * Male subjects must be willing not to donate sperm until 90 days following the last study drug administration. * Willing to take off dentures or mouth piercing at the time of dosing. Exclusion Criteria: * History of significant medical illness * Clinically significant abnormalities on screening tests/exams * History of or significant risk of committing suicide * Donation of plasma within 7 days prior to dosing * Donation or significant loss of blood within 8 weeks prior to the first dosing * Major surgery within 3 months or minor surgery within 1 month prior to admission * Use of prohibited prescription, over-the-counter medications or natural health products * Female subjects who are currently pregnant or lactating * Positive pregnancy test * Positive urine drug screen, urine cotinine test, or alcohol breath test * Use of tobacco or nicotine products within 1 month prior to Screening * Significant alcohol consumption * History of drug abuse within the previous year, or a positive drug screen * History of allergy to study medications * Part 1 only: Presence of orthodontic braces or orthodontic retention wires * Recent participation in a clinical research study * Not suitable for study in the opinion of the Principal Investigator

Locations (1)

Syneos Health Clinic Inc.

Québec, Quebec, Canada

Outcomes

Primary Outcomes

AUC0-inf of ecopipam when administered with itraconazole

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

AUC0-inf of ecopipam when administered without itraconazole

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

AUC0-inf of ecopipam when administered with rifampicin

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

AUC0-inf of ecopipam when administered without rifampicin

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

AUC0-t of ecopipam when administered with itraconazole

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

AUC0-t of ecopipam when administered without itraconazole

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

AUC0-t of ecopipam when administered with rifampicin

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

AUC0-t of ecopipam when administered without rifampicin

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

AUC0-inf of EBS-101-40853

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

AUC0-inf of ecopipam glucuronide

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

AUC0-inf of EBS-101-40853 glucuronide

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

AUC0-t of EBS-101-40853

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

AUC0-t of ecopipam glucuronide

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

AUC0-t of EBS-101-40853 glucuronide

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

Cmax of EBS-101-40853

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

Cmax of ecopipam glucuronide

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

Cmax of EBS-101-40853 glucuronide

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

T½ el of EBS-101-40853

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

T½ el of ecopipam glucuronide

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

T½ el of EBS-101-40853 glucuronide

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

AUC0-4 for ecopipam

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

AUC0-4 for EBS-101-40853

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

AUC0-4 for ecopipam glucuronide

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

AUC0-4 for EBS 101-40853 glucuronide

Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Time frame: Up to Day 21

Minimum Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score

Score from 0-5 where 0 is no response and 5 is responds readily. MOAA/S measures will be recorded at the indicated timepoints

Time frame: Up to Day 21

AUEC for Visual Analogue Scale (VAS)

Score from 0 - 100 where 0 is not sedated and 100 is very sedated. VAS measures will be recorded at the indicated timepoints.

Time frame: Up to Day 21

Maximum sedation for Visual Analogue Scale (VAS)

Score from 0 - 100 where 0 is not sedated and 100 is very sedated. VAS measures will be recorded at the indicated timepoints.

Time frame: Up to Day 21

AUEC for Reaction Time Index (RTI) score

Reaction time for subject to release the response button after presentation of target stimulus.

Time frame: Up to Day 21

Maximum sedation for Reaction Time Index (RTI) score

Reaction time for subject to release the response button after presentation of target stimulus.

Time frame: Up to Day 21

Safety and tolerability as demonstrated by AEs with itraconazole

Subjects will be continually monitored for adverse events

Time frame: Up to Day 30

Safety and tolerability as demonstrated by AEs without itraconazole

Subjects will be continually monitored for adverse events

Time frame: Up to Day 30

Safety and tolerability as demonstrated by AEs with rifampicin

Subjects will be continually monitored for adverse events

Time frame: Up to Day 30

Safety and tolerability as demonstrated by AEs without rifampicin

Subjects will be continually monitored for adverse events

Time frame: Up to Day 30

Safety and tolerability as demonstrated by Systolic blood pressure (SBP) and diastolic blood pressure (DBP) with itraconazole (mmHG)

Blood pressure will be assessed as part of vital signs

Time frame: Up to Day 21

Safety and tolerability as demonstrated by Systolic blood pressure (SBP) and diastolic blood pressure (DBP) without itraconazole(mmHG)

Blood pressure will be assessed as part of vital signs

Time frame: Up to Day 21

Safety and tolerability as demonstrated by Systolic blood pressure (SBP) and diastolic blood pressure (DBP) with rifampicin(mmHG)

Blood pressure will be assessed as part of vital signs

Time frame: Up to Day 21

Safety and tolerability as demonstrated by Systolic blood pressure (SBP) and diastolic blood pressure (DBP) without rifampicin(mmHG)

Blood pressure will be assessed as part of vital signs

Time frame: Up to Day 21

Heart rate with itraconazole (beats/minute)

Heart rate will be assessed as part of vital signs

Time frame: Up to Day 21

Heart rate without itraconazole (beats/minute)

Heart rate will be assessed as part of vital signs

Time frame: Up to Day 21

Heart rate with rifampicin (beats/minute)

Heart rate will be assessed as part of vital signs

Time frame: Up to Day 21

Heart rate without rifampicin (beats/minute)

Heart rate will be assessed as part of vital signs

Time frame: Up to Day 21

Respiratory rate pressure with itraconazole (breaths/minute)

Respiratory rate will be assessed as part of vital signs

Time frame: Up to Day 21

Respiratory rate without itraconazole (breaths/minute)

Respiratory rate will be assessed as part of vital signs

Time frame: Up to Day 21

Respiratory rate with rifampicin (breaths/minute)

Respiratory rate will be assessed as part of vital signs

Time frame: Up to Day 21

Respiratory rate without rifampicin (breaths/minute)

Respiratory rate will be assessed as part of vital signs

Time frame: Up to Day 21

Oral temperature with itraconazole (degrees Celsius)

Temperature will be assessed as part of vital signs

Time frame: Up to Day 21

Oral temperature without itraconazole (degrees Celsius)

Temperature will be assessed as part of vital signs

Time frame: Up to Day 21

Oral temperature with rifampicin (degrees Celsius)

Temperature will be assessed as part of vital signs

Time frame: Up to Day 21

Oral temperature without rifampicin (degrees Celsius)

Temperature will be assessed as part of vital signs

Time frame: Up to Day 21

Electrocardiogram (ECG) parameters: PR, RR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) with itraconazole (Milliseconds)

Twelve-lead ECGs will be obtained at the indicated timepoints

Time frame: Up to Day 21

Electrocardiogram (ECG) parameters: PR, RR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) without itraconazole (Milliseconds)

Twelve-lead ECGs will be obtained at the indicated timepoints

Time frame: Up to Day 21

Electrocardiogram (ECG) parameters: PR, RR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) with rifampicin (Milliseconds)

Twelve-lead ECGs will be obtained at the indicated timepoints

Time frame: Up to Day 21

Electrocardiogram (ECG) parameters: PR, RR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) without rifampicin (Milliseconds)

Twelve-lead ECGs will be obtained at the indicated timepoints

Time frame: Up to Day 21

Safety and tolerability as demonstrated by the Columbia Suicide Severity Rating Scale (C-SSRS)

C-SSRS to be administered at the indicated timepoints

Time frame: Up to Day 21

Values of white blood cell (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelets (1000/mm3)

Blood samples will be collected for the assessment of hematology parameters

Time frame: Up to Day 21

Value of hematocrit (percent)

Blood samples will be collected for the assessment of hematology parameters

Time frame: Up to Day 21

Value of hemoglobin (g/dL)

Blood samples will be collected for the assessment of hematology parameters

Time frame: Up to Day 21

Red blood cell (RBC) count (M/mm3)

Blood samples will be collected for the assessment of hematology parameters

Time frame: Up to Day 21

Values of sodium, potassium, chloride (mmol/L)

Blood samples will be collected for the assessment of clinical chemistry parameters

Time frame: Up to Day 21

Values of urea, phosphorus, calcium, glucose, and total, direct and indirect bilirubin (mg/dL)

Blood samples will be collected for the assessment of clinical chemistry parameters

Time frame: Up to Day 21

Values of albumin and total protein (g/dL)

Blood samples will be collected for the assessment of clinical chemistry parameters

Time frame: Up to Day 21

Values of alanine aminotransferase (ALT), aspartate aminotransferase (AST),alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), creatininephosphokinase (CPK), and creatinine (U/L)

Blood samples will be collected for the assessment of clinical chemistry parameters

Time frame: Up to Day 21

Values of urine specific gravity

Urine samples will be collected for the assessment of urine parameters

Time frame: Up to Day 21

Values of urine pH

Urine samples will be collected for the assessment of urine parameters

Time frame: Up to Day 21

Values of urine glucose

Urine samples will be collected for the assessment of urine parameters

Time frame: Up to Day 21

Values of urine protein

Urine samples will be collected for the assessment of urine parameters

Time frame: Up to Day 21

Values of urine blood

Urine samples will be collected for the assessment of urine parameters

Time frame: Up to Day 21

Values of urine ketones

Urine samples will be collected for the assessment of urine parameters

Time frame: Up to Day 21

Values of urine bilirubin and nitrite

Urine samples will be collected for the assessment of urine parameters

Time frame: Up to Day 21

Values of urobilinogen

Urine samples will be collected for the assessment of urine parameters

Time frame: Up to Day 21

Values of urine leukocyte esterase by dipstick

Urine samples will be collected for the assessment of urine parameters

Time frame: Up to Day 21