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

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ClinicalTrials.gov Identifier: NCT01947777
Recruitment Status : Completed
First Posted : September 20, 2013
Last Update Posted : July 31, 2017
Sponsor:
Information provided by (Responsible Party):
Verastem, Inc.

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
Healthy Drug: IPI-145 Drug: Rifampin 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
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 : October 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Rifampin


Intervention Details:
  • Drug: IPI-145
    25 mg oral capsule
  • Drug: Rifampin
    2x 300 mg oral capsule


Primary Outcome Measures :
  1. Pharmacokinetic parameters (AUC) of IPI-145 and its metabolite, IPI-656 [ Time Frame: Over 48 hours ]
  2. Pharmacokinetic parameters (Cmax) of IPI-145 and its metabolite, IPI-656 [ Time Frame: Over 48 hours ]
  3. Pharmacokinetic parameters (t1/2) of IPI-145 and its metabolite, IPI-656 [ Time Frame: Over 48 hours ]
  4. Plasma concentrations of IPI-145 and its metabolite, IPI-656 [ Time Frame: Over 48 hours ]

Secondary Outcome Measures :
  1. Incidence of adverse events following administration of IPI-145, rifampin, and the combination. [ Time Frame: 2 weeks ]
    Safety Findings



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947777


Locations
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United States, Kansas
PRA International, Inc
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Verastem, Inc.
Investigators
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Principal Investigator: Sandra Willsie PRA International, Inc
Study Chair: Hagop Youssoufian, MD Verastem, Inc.

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Responsible Party: Verastem, Inc.
ClinicalTrials.gov Identifier: NCT01947777     History of Changes
Other Study ID Numbers: IPI-145-11
First Posted: September 20, 2013    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017
Keywords provided by Verastem, Inc.:
Phase 1
Healthy subjects
DDI
CYP3A
Additional relevant MeSH terms:
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Rifampin
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers