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IPI-145 Single Ascending, Multiple Ascending, Food Effect and Drug-Drug-Interaction Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01549106
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : October 16, 2018
Information provided by (Responsible Party):
Verastem, Inc.

Brief Summary:
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-145 after single and repeat oral administration, and to evaluate the effects of food and ketoconazole on the plasma pharmacokinetics of IPI-145.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: IPI-145 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food and Ketoconazole on the Pharmacokinetics of IPI-145 When Administered to Healthy Adult Subjects
Study Start Date : August 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: IPI-145 Drug: IPI-145
Single ascending dose up to 6 cohorts; multiple ascending dose up to 4 cohorts; food effect arm; ketoconazole drug interaction study

Placebo Comparator: Placebo Drug: Placebo
Single ascending dose up to 6 cohorts; multiple ascending dose up to 4 cohorts; food effect arm

Primary Outcome Measures :
  1. Safety and tolerability assessments consisting of adverse events, vital signs, 12-lead ECG, clinical laboratory tests and physical examinations will be performed following IPI-145 single and repeat oral administration in healthy subjects [ Time Frame: 8 months ]
  2. Plasma concentrations of IPI-145 and metabolites [ Time Frame: 8 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Gender : male or female
  2. Age : 18-55 years, inclusive
  3. Body Mass Index (BMI) : 18.0-30.0 kg/m2
  4. Medical history without major pathology
  5. For males only: Willingness to use adequate contraception from the time of dosing and not donate sperm until 3 months after the follow-up visit
  6. Females who have a negative pregnancy test at screening and on each admission, and are of non-childbearing potential. Females of non-childbearing potential are defined as women who are surgically sterile or post-menopausal (defined as at least 1 year post cessation of menses and follicular stimulating hormone (FSH) >23.0 mIU/mL)
  7. Willing and able to sign the written Informed Consent Form (ICF)

Exclusion Criteria:

  1. Previous participation in the current study
  2. Evidence of clinically relevant pathology
  3. History of relevant drug and/or food allergies
  4. Part 4 only: Known or suspected adverse reaction or contraindication to the imidazole class of drugs

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 identifier (NCT number): NCT01549106

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PRA International
Zuidlaren, Netherlands, 9470 AE
Sponsors and Collaborators
Verastem, Inc.
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Study Chair: Hagop Youssoufian, MD Verastem, Inc.

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Responsible Party: Verastem, Inc. Identifier: NCT01549106     History of Changes
Other Study ID Numbers: IPI-145-01
2011-001944-31 ( EudraCT Number )
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: July 2017
Additional relevant MeSH terms:
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Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors