Pharmacokinetic Interaction Between Midazolam and ID-082 in Healthy Subjects

NCT ID: NCT03363984

Last Updated: 2018-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-27
• Study Completion Date: 2017-12-19

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Midazolam

Intervention Type: DRUG

Single oral administration of 2 mg midazolam under fasted conditions/outside of meal times

ID-082

Intervention Type: DRUG

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

Interventions

Midazolam

Single oral administration of 2 mg midazolam under fasted conditions/outside of meal times

Intervention Type: DRUG

ID-082

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabienne Le Gac

Role: STUDY_DIRECTOR

Idorsia Pharmaceuticals Ltd.

Locations

Simbec Research Limited

Merthyr Tydfil, Mid Galmorgan, United Kingdom

Countries

United Kingdom

Other Identifiers

ID-082-102

Identifier Type: -

Identifier Source: org_study_id