Pharmacokinetic Interaction Between Midazolam and ID-082 in Healthy Subjects

Healthy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03363984
• Other study ID #: ID-082-102
• Status: Completed
• Phase: Phase 1
• Start date: November 27, 2017
• Est. completion date: December 19, 2017

Study information

• Verified date: June 2018
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 19, 2017
• Est. primary completion date: December 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Midazolam
Single oral administration of 2 mg midazolam under fasted conditions/outside of meal times
• ID-082
Administration of ID-082 under fasted conditions/outside of meal times

Locations

Country	Name	City	State
United Kingdom	Simbec Research Limited	Merthyr Tydfil	Mid Galmorgan

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

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