Pharmacokinetics of Omeprazole and Midazolam When Co-administered With ACT-1014-6470

Idorsia Pharmaceuticals Ltd.20 enrolled

Overview

A study on whether ACT-1014-6470 has an effect on how the body takes up, distributes and gets rid of omeprazole and midazolam in healthy male subjects

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Drug Drug Interaction Healthy

Interventions

Treatment period ADRUG

Midazolam solution for oral administration. Omeprazole hard capsule for oral administration.

Treatment period BDRUG

ACT-1014-6470 soft capsule for oral administration. Midazolam solution for oral administration. Omeprazole hard capsule for oral administration.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Signed informed consent in a language understandable to the participant prior to any study-mandated procedure. * Healthy male participant aged between 18 and 45 years (inclusive) at Screening. * Body mass index of 18.5 to 28.0 kg/m2 (inclusive) at Screening. * Systolic blood pressure 100-140 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 beats per minute (inclusive), measured on either arm, after 5 min in the supine position at Screening and on Day -1. Exclusion Criteria: * Previous exposure to ACT-1014-6470. * Known hypersensitivity to ACT-1014-6470, omeprazole, substituted benzimidazoles, midazolam, or treatments of the same pharmacological classes, or any of their excipients. * History or clinical evidence of any disease and/or existence of any surgical or medical condition, which in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment (appendectomy and herniotomy allowed if performed more than 12 weeks prior to administration of \[first\] study treatment, cholecystectomy not allowed). * Previous treatment with any prescribed medications (including vaccines \[Vaccination regimen against COVID-19 completed less than 2 weeks prior to first study treatment administration or any vaccination against COVID-19 planned before end-of-study\]) or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 3 weeks prior to first study treatment administration. * Legal incapacity or limited legal capacity at Screening. * Participant with rare inherited issues of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency.

Locations (1)

CEPHA s.r.o.

Pilsen, Czechia

Outcomes

Primary Outcomes

Maximum plasma concentration (Cmax) of ACT-1014-6470, midazolam and omeprazole.

The plasma pharmacokinetic parameters of ACT-1014-6470, midazolam and omeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.

Time frame: Total duration: up to 11 days

Time to reach Cmax (tmax) of ACT-1014-6470, midazolam and omeprazole.

The plasma pharmacokinetic parameters of ACT-1014-6470, midazolam and omeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.

Time frame: Total duration: up to 11 days

The area under the plasma concentration-time curve (AUC) from zero to time t of the last measured concentration above the limit of quantification (AUC0-t) of ACT-1014-6470, midazolam and omeprazole.

The plasma pharmacokinetic parameters of ACT-1014-6470, midazolam and omeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.

Time frame: Total duration: up to 11 days

Area under the plasma concentration-time curve [AUC(0-12)] of omeprazole.

The plasma pharmacokinetic parameters of omeprazole will be derived by non-compartmental analysis of the plasma concentration-time profile.

Time frame: Total duration: up to 9 days

Area under the plasma concentration-time curve [AUC(0-24)] of midazolam and omeprazole.

The plasma pharmacokinetic parameters of midazolam and omeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.

Time frame: Total duration: up to 11 days

Area under the plasma concentration-time curve [AUC(0-inf)] of ACT-1014-6470, midazolam and omeprazole.

The plasma pharmacokinetic parameters of ACT-1014-6470, midazolam and omeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.

Data from ClinicalTrials.gov

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Secondary Outcomes

Maximum plasma concentration (Cmax) of 1-hydroxymidazolam and 5-hydroxyomeprazole.

The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.

Time frame: Total duration: up to 11 days

Time to reach Cmax (tmax) of 1-hydroxymidazolam and 5-hydroxyomeprazole.

The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.

Time frame: Total duration: up to 11 days

The area under the plasma concentration-time curve (AUC) from zero to time t of the last measured concentration above the limit of quantification (AUC0-t) of 1-hydroxymidazolam and 5-hydroxyomeprazole.

The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.

Time frame: Total duration: up to 11 days

Area under the plasma concentration-time curve [AUC(0-12)] of 5-hydroxyomeprazole.

The plasma pharmacokinetic parameters of 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.

Time frame: Total duration: up to 11 days

Area under the plasma concentration-time curve [AUC(0-24)] of 1-hydroxymidazolam and 5-hydroxyomeprazole.

The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.

Time frame: Total duration: up to 11 days

Area under the plasma concentration-time curve [AUC(0-inf)] of 1-hydroxymidazolam and 5-hydroxyomeprazole.

The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.

Time frame: Total duration: up to 11 days

The terminal half-life (t½) of 1-hydroxymidazolam and 5-hydroxyomeprazole.

The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.

Time frame: Total duration: up to 11 days

The metabolic ratio (MR) of 1-hydroxymidazolam to midazolam .

Time frame: Total duration: up to 11 days

The metabolic ratio (MR) of 5-hydroxyomeprazole to omeprazole.

Time frame: Total duration: up to 11 days

Number of participants with treatment-emergent adverse events as a measure of safety and tolerability.

An adverse event is an unfavorable and unintended sign (including an abnormal laboratory finding, an abnormal electrocardiogram). A treatment-emergent adverse event is any adverse event temporally associated with the use of a study treatment, whether or not considered related to the study treatment.

Time frame: Total duration: up to 11 days