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Pharmacokinetic Interaction Between Midazolam and ID-082 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03363984
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Midazolam Drug: ID-082 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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.
Actual Study Start Date : November 27, 2017
Actual Primary Completion Date : December 19, 2017
Actual Study Completion Date : December 19, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Midazolam & ID-082
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.
Drug: Midazolam
Single oral administration of 2 mg midazolam under fasted conditions/outside of meal times

Drug: ID-082
Administration of ID-082 under fasted conditions/outside of meal times




Primary Outcome Measures :
  1. Cmax of midazolam [ Time Frame: From baseline to EOS (i.e. for up to 16 days) ]
    Maximum plasma concentration

  2. 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


Secondary Outcome Measures :
  1. Cmax of 1-hydroxymidazolam [ Time Frame: From baseline to EOS (i.e. for up to 16 days) ]
    Maximum plasma concentration

  2. 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) ]
    Area under the plasma concentration-time curve from zero to infinity

  3. tmax of midazolam and 1-hydroxymidazolam [ Time Frame: From baseline to EOS (i.e. for up to 16 days) ]
    Time to reach maximum plasma concentration

  4. t½ of midazolam and 1-hydroxymidazolam [ Time Frame: From baseline to EOS (i.e. for up to 16 days) ]
    Terminal elimination half-life

  5. Total body apparent plasma clearance (CL/F) of midazolam [ Time Frame: From baseline to EOS (i.e. for up to 16 days) ]
  6. 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) ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363984


Locations
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United Kingdom
Simbec Research Limited
Merthyr Tydfil, Mid Galmorgan, United Kingdom, CF48 4DR
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Investigators
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Study Director: Fabienne Le Gac Idorsia Pharmaceuticals Ltd.
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Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT03363984    
Other Study ID Numbers: ID-082-102
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action