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

NCT05123820 | Completed Phase 1

• 2 other identifiers: ID-087-1052021-003615-26
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drug Drug Interaction; Healthy

Keywords

ACT-1014-6470; Omeprazole; Midazolam

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  Total duration: up to 11 days

• Apparent total body clearance (CL/F) 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.

  Total duration: up to 11 days

• The terminal half-life (t½) 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.

  Total duration: up to 11 days

Secondary Outcomes (10)

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

  Total duration: up to 11 days

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

  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.

  Total duration: up to 11 days

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

  Total duration: up to 11 days

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

  Total duration: up to 11 days

Study Arms (1)

ACT-1014-6470, Midazolam and Omeprazole

EXPERIMENTAL

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; Drug: Treatment period B

Interventions

Treatment period A DRUG

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

Also known as: Midazolam and Omeprazole

ACT-1014-6470, Midazolam and Omeprazole

Treatment period B DRUG

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

Also known as: ACT-1014-6470, Midazolam and Omeprazole

ACT-1014-6470, Midazolam and Omeprazole

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (1)

CEPHA s.r.o.

Pilsen, 32300, Czechia

Location

MeSH Terms

Interventions

Midazolam; Omeprazole; ACT-1014-6470

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles

Study Officials

• Clinical Trials

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two-period, fixed-sequence study

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 17, 2021
• Study Start: November 13, 2021
• Primary Completion: November 24, 2021
• Study Completion: November 24, 2021
• Last Updated: January 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)