Pharmacokinetic Interaction Between Midazolam and ID-082 in Healthy Subjects

NCT03363984 | Completed Phase 1

• 1 other identifier: ID-082-102
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Cmax of midazolam

  Maximum plasma concentration

  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

  From baseline to EOS (i.e. for up to 16 days)

Secondary Outcomes (6)

• Cmax of 1-hydroxymidazolam

  From baseline to EOS (i.e. for up to 16 days)

• AUC0-inf of midazolam and 1-hydroxymidazolam and AUC0-24 of 1-hydroxymidazolam

  From baseline to EOS (i.e. for up to 16 days)

• tmax of midazolam and 1-hydroxymidazolam

  From baseline to EOS (i.e. for up to 16 days)

• t½ of midazolam and 1-hydroxymidazolam

  From baseline to EOS (i.e. for up to 16 days)

• Total body apparent plasma clearance (CL/F) of midazolam

  From baseline to EOS (i.e. for up to 16 days)

Study Arms (1)

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.

Drug: Midazolam; Drug: ID-082

Interventions

Midazolam DRUG

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

Midazolam & ID-082

ID-082 DRUG

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

Midazolam & ID-082

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (1)

Simbec Research Limited

Merthyr Tydfil, Mid Galmorgan, CF48 4DR, United Kingdom

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Fabienne Le Gac

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: December 6, 2017
• Study Start: November 27, 2017
• Primary Completion: December 19, 2017
• Study Completion: December 19, 2017
• Last Updated: June 27, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)