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

NCT ID: NCT01947777

Last Updated: 2021-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2013-12-31

Brief Summary

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

Detailed Description

• In Treatment Period 1, subjects will receive a single 25 mg oral dose of IPI-145
• In Treatment Period 2, on Days 3-9, the same subjects will receive once daily (QD) oral doses of 600 mg rifampin; on Day 9, subjects will receive a single oral dose of 25 mg IPI-145 concomitantly administered with 600 mg of rifampin

Conditions

Healthy

Study Design

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

Interventions

IPI-145

25 mg oral capsule

Intervention Type: DRUG

Rifampin

2x 300 mg oral capsule

Intervention Type: DRUG

Eligibility Criteria

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
• Consumption of any nutrients known to modulate cytochrome P450 enzyme activity within 14 days prior to administration of study drug, during the study, and until after discharge

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SecuraBio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hagop Youssoufian, MD

Role: STUDY_CHAIR

Verastem, Inc.

Locations

PRA International, Inc

Lenexa, Kansas, United States

Countries

United States

Other Identifiers

IPI-145-11

Identifier Type: -

Identifier Source: org_study_id