Drug Drug InteractionPhase 1NCT05123820
Pharmacokinetics of Omeprazole and Midazolam When Co-administered With ACT-1014-6470
A Phase 1 study testing Treatment period A and Treatment period B in people with Drug Drug Interaction and Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in Czechia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Drug Interaction, Healthy
- What is being tested?
- Treatment period A and Treatment period B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 13 Nov 2021to 24 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Treatment period A, Treatment period B
- Keywords
- ACT-1014-6470, Omeprazole, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment period ADrug
Also called Midazolam and Omeprazole
Midazolam solution for oral administration. Omeprazole hard capsule for oral administration.
Treatment period BDrug
Also called ACT-1014-6470, Midazolam and Omeprazole
ACT-1014-6470 soft capsule for oral administration. Midazolam solution for oral administration. Omeprazole hard capsule for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Treatment period A; Drug: Treatment period B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Total duration: up to 11 days
Secondary outcomes (10)
Maximum plasma concentration (Cmax) of 1-hydroxymidazolam and 5-hydroxyomeprazole.
The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.
Measured: Total duration: up to 11 days
Time to reach Cmax (tmax) of 1-hydroxymidazolam and 5-hydroxyomeprazole.
The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.
Measured: 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.
The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.
Measured: Total duration: up to 11 days
Area under the plasma concentration-time curve [AUC(0-12)] of 5-hydroxyomeprazole.
The plasma pharmacokinetic parameters of 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.
Measured: Total duration: up to 11 days
Area under the plasma concentration-time curve [AUC(0-24)] of 1-hydroxymidazolam and 5-hydroxyomeprazole.
The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.
Measured: Total duration: up to 11 days
Area under the plasma concentration-time curve [AUC(0-inf)] of 1-hydroxymidazolam and 5-hydroxyomeprazole.
The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.
Measured: Total duration: up to 11 days
The terminal half-life (t½) of 1-hydroxymidazolam and 5-hydroxyomeprazole.
The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles.
Measured: Total duration: up to 11 days
The metabolic ratio (MR) of 1-hydroxymidazolam to midazolam .
Measured: Total duration: up to 11 days
The metabolic ratio (MR) of 5-hydroxyomeprazole to omeprazole.
Measured: Total duration: up to 11 days
Number of participants with treatment-emergent adverse events as a measure of safety and tolerability.
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.
Measured: Total duration: up to 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start13 Nov 2021
- Primary completion24 Nov 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Drug InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Two-period, fixed-sequence study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123820
- Sponsor's protocol ID
- ID-087-105
- Other IDs
- 2021-003615-26
- Status last verified
- Jan 2022
- First submitted
- 5 Nov 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05123820
- Acronym / sponsor ID
- ID-087-105
- Conditions
- Drug Drug Interaction, Healthy
- Keywords
- ACT-1014-6470, Omeprazole, Midazolam
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2021 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Two-period, fixed-sequence study
| Arm | Type | Receives |
|---|---|---|
| ACT-1014-6470, Midazolam and Omeprazole | Experimental | Drug: Treatment period A, Drug: Treatment period BTreatment 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment period AAlso: Midazolam and OmeprazoleMidazolam solution for oral administration. Omeprazole hard capsule for oral administration. | Drug | ACT-1014-6470, Midazolam and Omeprazole |
| Treatment period BAlso: ACT-1014-6470, Midazolam and OmeprazoleACT-1014-6470 soft capsule for oral administration. Midazolam solution for oral administration. Omeprazole hard capsule for oral administration. | Drug | ACT-1014-6470, Midazolam and Omeprazole |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
10 secondary outcomes
Maximum plasma concentration (Cmax) of 1-hydroxymidazolam and 5-hydroxyomeprazole.
Time frame: 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 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
Area under the plasma concentration-time curve [AUC(0-12)] of 5-hydroxyomeprazole.
Time frame: 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
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 terminal half-life (t½) of 1-hydroxymidazolam and 5-hydroxyomeprazole.
Time frame: Total duration: up to 11 days
The metabolic ratio (MR) of 1-hydroxymidazolam to midazolam .
Time frame: Total duration: up to 11 days
The metabolic ratio (MR) of 5-hydroxyomeprazole to omeprazole.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Idorsia Pharmaceuticals Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment period A and Treatment period B in people with Drug Drug Interaction and Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration (Cmax) of ACT-1014-6470, midazolam and omeprazole. (time frame: Total duration: up to 11 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.