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Completed

NCT Number: NCT05123820

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

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

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Key information

Conditions

Drug Drug Interaction Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CEPHA s.r.o.

Pilsen, 32300, Czechia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Treatment period A

Drug

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

Other names: 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.

Other names: ACT-1014-6470, Midazolam and Omeprazole

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

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

    Time frame: Total duration: up to 11 days

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

    Time frame: Total duration: up to 11 days

  10. 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.

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 17, 2021
Registry last updated
Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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