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

Sponsor
SecuraBio (Industry)
Overall Status
Completed
CT.gov ID
NCT01947777
Collaborator
(none)
14
1
2
7

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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

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 Rifampin (a CYP3A Inducer) on the Pharmacokinetics of IPI-145 in Healthy Subjects
Study Start Date :
Oct 1, 2013
Actual Primary Completion Date :
Nov 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Outcome Measures

Primary Outcome Measures

  1. Pharmacokinetic parameters (AUC) of IPI-145 and its metabolite, IPI-656 [Over 48 hours]

  2. Pharmacokinetic parameters (Cmax) of IPI-145 and its metabolite, IPI-656 [Over 48 hours]

  3. Pharmacokinetic parameters (t1/2) of IPI-145 and its metabolite, IPI-656 [Over 48 hours]

  4. Plasma concentrations of IPI-145 and its metabolite, IPI-656 [Over 48 hours]

Secondary Outcome Measures

  1. Incidence of adverse events following administration of IPI-145, rifampin, 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

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 PRA International, Inc 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:
NCT01947777
Other Study ID Numbers:
  • IPI-145-11
First Posted:
Sep 20, 2013
Last Update Posted:
Mar 17, 2021
Last Verified:
Mar 1, 2021
Keywords provided by SecuraBio
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 17, 2021