A Study to Assess Adverse Events, Tolerability and How Single and Ascending Oral Doses of Nacresertib Move Through the Body In Healthy Adult Participants

AbbVie93 enrolled

Overview

The objectives for this 2 Part study are to assess the safety, tolerability, and pharmacokinetics following single ascending oral doses of nacresertib in healthy adult participants (Part 1) and to assess the safety, tolerability, and pharmacokinetics following multiple ascending oral doses in healthy adult participants (Part 2).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

nacresertibDRUG

Oral

PlaceboDRUG

Oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: \-- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG. Exclusion Criteria: * History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness. * History of any clinically significant sensitivity or allergy to any medication or food. * History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\]

Locations (1)

Acpru /Id# 274374

Grayslake, Illinois, United States

Outcomes

Primary Outcomes

Maximum Observed Plasma Concentration (Cmax) of nacresertib

Cmax of nacresertib

Time frame: Up to Day 19

Time to Cmax (Tmax) of nacresertib

Tmax of nacresertib

Time frame: Up to Day 19

Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of nacresertib

AUCt of nacresertib

Time frame: Up to Day 19

AUC From Time 0 to the Time Infinity (AUCinf) of nacresertib

AUCinf of nacresertib

Time frame: Up to Day 19

Part 2 Only: Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of nacresertib

AUCtau of nacresertib

Time frame: Up to Day 14

Terminal Phase Elimination Rate Constant (Beta) of nacresertib

Beta of nacresertib

Time frame: Up to Day 19

Terminal Phase Elimination Half-Life (t1/2) of nacresertib

t1/2 of nacresertib

Time frame: Up to Day 19

Dose Normalized Cmax

Time frame: Up to Day 19

Dose Normalized AUCs

Time frame: Up to Day 19

Data from ClinicalTrials.gov

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