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

Idorsia Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy; Drug Drug Interaction

Treatments: Drug: Treatment period B; Drug: Treatment period A

Study type: Interventional

Funder types: Industry

Identifiers

NCT05123820

ID-087-105

2021-003615-26 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

ACT-1014-6470, Midazolam and Omeprazole

Experimental group

Description:

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.

Treatment:

Drug: Treatment period A

Drug: Treatment period B