Clinical trial NCT05123820: Pharmacokinetics of Omeprazole and Midazolam When Co-administered With ACT-1014-6470
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Drug Interaction
Healthy
Keywords: ACT-1014-6470
Omeprazole
Midazolam
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-17
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Two-period, fixed-sequence study
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of ACT-1014-6470, midazolam and omeprazole.
timeFrame: Total duration: up to 11 days
measure: Time to reach Cmax (tmax) of ACT-1014-6470, midazolam and omeprazole.
timeFrame: Total duration: up to 11 days
measure: 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.
timeFrame: Total duration: up to 11 days
measure: Area under the plasma concentration-time curve [AUC(0-12)] of omeprazole.
timeFrame: Total duration: up to 9 days
measure: Area under the plasma concentration-time curve [AUC(0-24)] of midazolam and omeprazole.
timeFrame: Total duration: up to 11 days
measure: Area under the plasma concentration-time curve [AUC(0-inf)] of ACT-1014-6470, midazolam and omeprazole.
timeFrame: Total duration: up to 11 days
measure: Apparent total body clearance (CL/F) of ACT-1014-6470, midazolam and omeprazole.
timeFrame: Total duration: up to 11 days
measure: The terminal half-life (t½) of ACT-1014-6470, midazolam and omeprazole.
timeFrame: Total duration: up to 11 days
Secondary outcomes:
measure: Maximum plasma concentration (Cmax) of 1-hydroxymidazolam and 5-hydroxyomeprazole.
timeFrame: Total duration: up to 11 days
measure: Time to reach Cmax (tmax) of 1-hydroxymidazolam and 5-hydroxyomeprazole.
timeFrame: Total duration: up to 11 days
measure: 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.
timeFrame: Total duration: up to 11 days
measure: Area under the plasma concentration-time curve [AUC(0-12)] of 5-hydroxyomeprazole.
timeFrame: Total duration: up to 11 days
measure: Area under the plasma concentration-time curve [AUC(0-24)] of 1-hydroxymidazolam and 5-hydroxyomeprazole.
timeFrame: Total duration: up to 11 days
measure: Area under the plasma concentration-time curve [AUC(0-inf)] of 1-hydroxymidazolam and 5-hydroxyomeprazole.
timeFrame: Total duration: up to 11 days
measure: The terminal half-life (t½) of 1-hydroxymidazolam and 5-hydroxyomeprazole.
timeFrame: Total duration: up to 11 days
measure: The metabolic ratio (MR) of 1-hydroxymidazolam to midazolam .
timeFrame: Total duration: up to 11 days
measure: The metabolic ratio (MR) of 5-hydroxyomeprazole to omeprazole.
timeFrame: Total duration: up to 11 days
measure: Number of participants with treatment-emergent adverse events as a measure of safety and tolerability.
timeFrame: Total duration: up to 11 days
Other outcomes:
Locations:
city: Pilsen
country: Czechia
facility: CEPHA s.r.o.
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials
role: STUDY_DIRECTOR
References: