HealthyPhase 1NCT03363984
Pharmacokinetic Interaction Between Midazolam and ID-082 in Healthy Subjects
A Phase 1 study testing Midazolam and ID-082 in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in United Kingdom.
Trial summary
A clinical study in healthy male subjects to investigate whether the administration of ID-082 can affect the fate in the body (amount and time of presence in the blood) of midazolam. 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
- Healthy
- What is being tested?
- Midazolam and ID-082
- 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 siteUnited Kingdom
- Study dates
- 27 Nov 2017to 19 Dec 2017
- 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 the local language prior to any study-mandated procedure;
- Healthy male subjects aged 18 to 45 years (inclusive) at screening;
- Male subject with a female partner of childbearing potential or a pregnant partner must agree to use a condom from screening, during the study, and for at least 3 months after last study treatment intake;
- Body mass index of 18.0 to 30.0 kg/m2 (inclusive) at screening;
- Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.
Who cannot join
- Contraindication or known hypersensitivity to ID-082, midazolam or drugs of the same classes, or any of their excipients;
- Modified Swiss Narcolepsy Scale total score < 0 at Screening or history of narcolepsy or cataplexy;
- History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study treatment;
- Known hypersensitivity or allergy to natural rubber latex;
- Known hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase insufficiency;
- Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions;
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Simbec Research Limited
Merthyr Tydfil, Mid Galmorgan, CF48 4DR
About this study
Official title: A Single-center, Open-label Study to Investigate the Effect of a Single Oral Dose and Repeated Oral Doses of ID-082 on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxymidazolam in Healthy Male Subjects.
A clinical study in healthy male subjects to investigate whether the administration of ID-082 can affect the fate in the body (amount and time of presence in the blood) of midazolam.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Single oral administration of 2 mg midazolam under fasted conditions/outside of meal times
ID-082Drug
Administration of ID-082 under fasted conditions/outside of meal times
| Study group | Role | What they receive |
|---|---|---|
| Midazolam & ID-082 | Experimental | Single oral administration of 2 mg midazolam on Day 1, Day 2, and Day 11. Administration of ID-082 from Day 2 through Day 11. Receives: Drug: Midazolam; Drug: ID-082 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of midazolam
Maximum plasma concentration
Measured: From baseline to EOS (i.e. for up to 16 days)
AUC0-24 of midazolam
Area under the plasma concentration-time curvefrom time zero to 24 h
Measured: From baseline to EOS (i.e. for up to 16 days)
Secondary outcomes (6)
Cmax of 1-hydroxymidazolam
Maximum plasma concentration
Measured: From baseline to EOS (i.e. for up to 16 days)
AUC0-inf of midazolam and 1-hydroxymidazolam and AUC0-24 of 1-hydroxymidazolam
Area under the plasma concentration-time curve from zero to infinity
Measured: From baseline to EOS (i.e. for up to 16 days)
tmax of midazolam and 1-hydroxymidazolam
Time to reach maximum plasma concentration
Measured: From baseline to EOS (i.e. for up to 16 days)
t½ of midazolam and 1-hydroxymidazolam
Terminal elimination half-life
Measured: From baseline to EOS (i.e. for up to 16 days)
Total body apparent plasma clearance (CL/F) of midazolam
Measured: From baseline to EOS (i.e. for up to 16 days)
Metabolic ratio (MR) of the AUC0-24 of 1-hydroxymidazolam to the AUC0-24 of midazolam
Measured: From baseline to EOS (i.e. for up to 16 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start27 Nov 2017
- Primary completion19 Dec 2017
- Study completion19 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 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
- Fabienne Le Gac, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363984
- Sponsor's protocol ID
- ID-082-102
- Status last verified
- Jun 2018
- First submitted
- 21 Nov 2017
- Last updated
- 27 Jun 2018
- 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 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label Study to Investigate the Effect of a Single Oral Dose and Repeated Oral Doses of ID-082 on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxymidazolam in Healthy Male Subjects.
- ClinicalTrials.gov ID
- NCT03363984
- Acronym / sponsor ID
- ID-082-102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 19 Dec 2017 (actual)
- Study completion
- 19 Dec 2017 (actual)
- First posted
- 6 Dec 2017 (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 clinical study in healthy male subjects to investigate whether the administration of ID-082 can affect the fate in the body (amount and time of presence in the blood) of midazolam.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Midazolam & ID-082 | Experimental | Drug: Midazolam, Drug: ID-082Single oral administration of 2 mg midazolam on Day 1, Day 2, and Day 11. Administration of ID-082 from Day 2 through Day 11. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed informed consent in the local language prior to any study-mandated procedure;
- Healthy male subjects aged 18 to 45 years (inclusive) at screening;
- Male subject with a female partner of childbearing potential or a pregnant partner must agree to use a condom from screening, during the study, and for at least 3 months after last study treatment intake;
- Body mass index of 18.0 to 30.0 kg/m2 (inclusive) at screening;
- Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.
Key exclusion criteria (7 listed)
- Contraindication or known hypersensitivity to ID-082, midazolam or drugs of the same classes, or any of their excipients;
- Modified Swiss Narcolepsy Scale total score < 0 at Screening or history of narcolepsy or cataplexy;
- History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study treatment;
- Known hypersensitivity or allergy to natural rubber latex;
- Known hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase insufficiency;
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 |
|---|---|---|
| MidazolamSingle oral administration of 2 mg midazolam under fasted conditions/outside of meal times | Drug | Midazolam & ID-082 |
| ID-082Administration of ID-082 under fasted conditions/outside of meal times | Drug | Midazolam & ID-082 |
Primary outcome
Cmax of midazolam
Time frame: From baseline to EOS (i.e. for up to 16 days)
Maximum plasma concentration
AUC0-24 of midazolam
Time frame: From baseline to EOS (i.e. for up to 16 days)
Area under the plasma concentration-time curvefrom time zero to 24 h
6 secondary outcomes
Cmax of 1-hydroxymidazolam
Time frame: From baseline to EOS (i.e. for up to 16 days)
AUC0-inf of midazolam and 1-hydroxymidazolam and AUC0-24 of 1-hydroxymidazolam
Time frame: From baseline to EOS (i.e. for up to 16 days)
tmax of midazolam and 1-hydroxymidazolam
Time frame: From baseline to EOS (i.e. for up to 16 days)
t½ of midazolam and 1-hydroxymidazolam
Time frame: From baseline to EOS (i.e. for up to 16 days)
Total body apparent plasma clearance (CL/F) of midazolam
Time frame: From baseline to EOS (i.e. for up to 16 days)
Metabolic ratio (MR) of the AUC0-24 of 1-hydroxymidazolam to the AUC0-24 of midazolam
Time frame: From baseline to EOS (i.e. for up to 16 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 27 Jun 2018.
- 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.
Fabienne Le Gac 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 Midazolam and ID-082 in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in United Kingdom.
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 5 inclusion and 7 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 27 Jun 2018. 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 United Kingdom. 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?
Cmax of midazolam (time frame: From baseline to EOS (i.e. for up to 16 days)). The study lists 2 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 27 Jun 2018.