Phase 1 Study in Healthy Subjects to Evaluate the Effect of IPI-145 on the Pharmacokinetics of Midazolam

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT01925911
• Lead Sponsor: SecuraBio

Brief Summary

To evaluate the effect of IPI-145 on the pharmacokinetics of midazolam, a cytochrome P450 3A (CYP3A) substrate; to assess the safety and tolerability of IPI-145 when administered with midazolam in healthy subjects.

Detailed Description

* In Treatment Period 1, subjects will receive a single 2 mg oral dose of midazolam.

* In Treatment Period 2, on Days 2-6, the same subjects will receive twice daily (BID) oral doses of 25 mg IPI-145; on Day 6, subjects will receive the morning dose of 25 mg IPI-145 concomitantly administered with 2 mg of midazolam.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-15
• Study First Submitted QC: 2013-08-16
• Study First Posted: 2013-08-20
• Primary Completion: 2013-09
• Study Completion: 2013-10
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Healthy men or women of non-childbearing potential between 18-50 years of age
• Body Mass Index (BMI): 18.0 - 32.0 kg/m2.
• In good health, determined by no clinically significant findings from clinical evaluations
• Provided written informed consent prior to any study specific procedures

Exclusion Criteria

• Women of childbearing potential
• Evidence of clinically significant medical conditions
• History of gastrointestinal disease or surgery that may affect drug absorption
• Positive or indeterminate tuberculosis-spot test at screening
• Any active infection at the time of screening or admission
• Subjects with acute narrow-angle glaucoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of midazolam and 1-hydroxy-midazolam	Over 24 hours
Pharmacokinetic parameters (Cmax) of midazolam and 1-hydroxy-midazolam	Over 24 hours
Pharmacokinetic parameters (AUC) of midazolam and 1-hydroxy-midazolam	Over 24 hours
Pharmacokinetic parameters (t1/2) of midazolam and 1-hydroxy-midazolam	Over 24 hours

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events following of administration midazolam, IPI-145 and the combination	2 weeks	Safety Findings

Trial Locations

Locations (1)

PRA International; 🇺🇸 Lenexa, Kansas, United States