Pharmacokinetic Interaction Between Midazolam and ID-082 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Midazolam; Drug: ID-082

• Registration Number: NCT03363984
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-21
• Study Start: 2017-11-27
• Study First Submitted QC: 2017-11-30
• Study First Posted: 2017-12-06
• Primary Completion: 2017-12-19
• Study Completion: 2017-12-19
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Midazolam & ID-082	Midazolam	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.
Midazolam & ID-082	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.

Primary Outcome Measures

Name	Time	Method
Cmax of midazolam	From baseline to EOS (i.e. for up to 16 days)	Maximum plasma concentration
AUC0-24 of midazolam	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

Name	Time	Method
Cmax of 1-hydroxymidazolam	From baseline to EOS (i.e. for up to 16 days)	Maximum plasma concentration
AUC0-inf of midazolam and 1-hydroxymidazolam and AUC0-24 of 1-hydroxymidazolam	From baseline to EOS (i.e. for up to 16 days)	Area under the plasma concentration-time curve from zero to infinity
tmax of midazolam and 1-hydroxymidazolam	From baseline to EOS (i.e. for up to 16 days)	Time to reach maximum plasma concentration
t½ of midazolam and 1-hydroxymidazolam	From baseline to EOS (i.e. for up to 16 days)	Terminal elimination half-life
Total body apparent plasma clearance (CL/F) of midazolam	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	From baseline to EOS (i.e. for up to 16 days)

Trial Locations

Locations (1)

Simbec Research Limited; 🇬🇧 Merthyr Tydfil, Mid Galmorgan, United Kingdom