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

January 13, 2022 updated by: Idorsia Pharmaceuticals Ltd.

A Single-center, Open-label, Two-period, Fixed-sequence Study to Investigate the Effect of a Single Oral Dose of ACT-1014-6470 on the Pharmacokinetics of Omeprazole, Midazolam, and Their Metabolites in Healthy Male Subjects

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Pilsen, Czechia, 32300
        • CEPHA s.r.o.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACT-1014-6470, Midazolam and Omeprazole

Treatment Period A (Day 1 to Day 2) The plan is that all participants will receive treatment A and then treatment B.

  • A single oral dose of midazolam 2 mg and a single oral dose of omeprazole 20 mg on Day 1.

Treatment Period B (Day 8 to Day 11)

  • A single oral dose of 100 mg ACT-1014-6470, a single oral dose of 20 mg omeprazole, and a single oral dose of 2 mg midazolam on Day 8.
Drug: Treatment period A
Midazolam solution for oral administration. Omeprazole hard capsule for oral administration.
Other Names:
  • Midazolam and Omeprazole
Drug: Treatment period B
ACT-1014-6470 soft capsule for oral administration. Midazolam solution for oral administration. Omeprazole hard capsule for oral administration.
Other Names:
  • ACT-1014-6470, Midazolam and Omeprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration (Cmax) of ACT-1014-6470, midazolam and omeprazole.
Time Frame: Total duration: up to 11 days
The plasma pharmacokinetic parameters of ACT-1014-6470, midazolam and omeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.
Total duration: up to 11 days
Time to reach Cmax (tmax) of ACT-1014-6470, midazolam and omeprazole.
Time Frame: Total duration: up to 11 days
The plasma pharmacokinetic parameters of ACT-1014-6470, midazolam and omeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.
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.
Time Frame: Total duration: up to 11 days
The plasma pharmacokinetic parameters of ACT-1014-6470, midazolam and omeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.
Total duration: up to 11 days
Area under the plasma concentration-time curve [AUC(0-12)] of omeprazole.
Time Frame: Total duration: up to 9 days
The plasma pharmacokinetic parameters of omeprazole will be derived by non-compartmental analysis of the plasma concentration-time profile.
Total duration: up to 9 days
Area under the plasma concentration-time curve [AUC(0-24)] of midazolam and omeprazole.
Time Frame: Total duration: up to 11 days
The plasma pharmacokinetic parameters of midazolam and omeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.
Total duration: up to 11 days
Area under the plasma concentration-time curve [AUC(0-inf)] of ACT-1014-6470, midazolam and omeprazole.
Time Frame: Total duration: up to 11 days
The plasma pharmacokinetic parameters of ACT-1014-6470, midazolam and omeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.
Total duration: up to 11 days
Apparent total body clearance (CL/F) of ACT-1014-6470, midazolam and omeprazole.
Time Frame: Total duration: up to 11 days
The plasma pharmacokinetic parameters of ACT-1014-6470, midazolam and omeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.
Total duration: up to 11 days
The terminal half-life (t½) of ACT-1014-6470, midazolam and omeprazole.
Time Frame: Total duration: up to 11 days
The plasma pharmacokinetic parameters of ACT-1014-6470, midazolam and omeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.
Total duration: up to 11 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration (Cmax) of 1-hydroxymidazolam and 5-hydroxyomeprazole.
Time Frame: Total duration: up to 11 days
The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.
Total duration: up to 11 days
Time to reach Cmax (tmax) of 1-hydroxymidazolam and 5-hydroxyomeprazole.
Time Frame: Total duration: up to 11 days
The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.
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.
Time Frame: Total duration: up to 11 days
The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.
Total duration: up to 11 days
Area under the plasma concentration-time curve [AUC(0-12)] of 5-hydroxyomeprazole.
Time Frame: Total duration: up to 11 days
The plasma pharmacokinetic parameters of 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.
Total duration: up to 11 days
Area under the plasma concentration-time curve [AUC(0-24)] of 1-hydroxymidazolam and 5-hydroxyomeprazole.
Time Frame: Total duration: up to 11 days
The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.
Total duration: up to 11 days
Area under the plasma concentration-time curve [AUC(0-inf)] of 1-hydroxymidazolam and 5-hydroxyomeprazole.
Time Frame: Total duration: up to 11 days
The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.
Total duration: up to 11 days
The terminal half-life (t½) of 1-hydroxymidazolam and 5-hydroxyomeprazole.
Time Frame: Total duration: up to 11 days
The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.
Total duration: up to 11 days
The metabolic ratio (MR) of 1-hydroxymidazolam to midazolam .
Time Frame: Total duration: up to 11 days
Total duration: up to 11 days
The metabolic ratio (MR) of 5-hydroxyomeprazole to omeprazole.
Time Frame: Total duration: up to 11 days
Total duration: up to 11 days
Number of participants with treatment-emergent adverse events as a measure of safety and tolerability.
Time Frame: Total duration: up to 11 days
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.
Total duration: up to 11 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Idorsia Pharmaceuticals Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2021

Primary Completion (Actual)

November 24, 2021

Study Completion (Actual)

November 24, 2021

Study Registration Dates

First Submitted

November 5, 2021

First Submitted That Met QC Criteria

November 5, 2021

First Posted (Actual)

November 17, 2021

Study Record Updates

Last Update Posted (Actual)

January 14, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID-087-105
  • 2021-003615-26 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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