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

• Sponsor: SecuraBio (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01925911
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Duration (Months): 2
• Patients Per Site Per Month: 7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: IPI-145; Drug: Midazolam	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase 1, Open-Label, Single-Sequence, 2-Period Study to Evaluate the Effect of IPI-145 on Single-Dose Pharmacokinetics of Midazolam (a CYP3A Substrate) in Healthy Subjects
• Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetic parameters (AUC) of midazolam and 1-hydroxy-midazolam [Over 24 hours]

2. Pharmacokinetic parameters (Cmax) of midazolam and 1-hydroxy-midazolam [Over 24 hours]

3. Pharmacokinetic parameters (t1/2) of midazolam and 1-hydroxy-midazolam [Over 24 hours]

4. Plasma concentrations of midazolam and 1-hydroxy-midazolam [Over 24 hours]

Secondary Outcome Measures

1. Incidence of adverse events following of administration midazolam, IPI-145 and the combination [2 weeks]

   Safety Findings

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA International	Lenexa	Kansas	United States	66219

Sponsors and Collaborators

• SecuraBio

Investigators

• Study Chair: Hagop Youssoufian, MD, Verastem, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SecuraBio
• ClinicalTrials.gov Identifier: NCT01925911
• Other Study ID Numbers: IPI-145-10
• First Posted: Aug 20, 2013
• Last Update Posted: Mar 17, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by SecuraBio: Phase 1; Healthy subjects; DDI; CYP3A
• Additional relevant MeSH terms: Midazolam

Study Results

No Results Posted as of Mar 17, 2021