IPI-145 Single Ascending, Multiple Ascending, Food Effect and Drug-Drug-Interaction Study
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
2 other identifiers
interventional
106
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Aug 2011
Typical duration for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 10, 2012
CompletedFirst Posted
Study publicly available on registry
March 8, 2012
CompletedMarch 17, 2021
March 1, 2021
6 months
February 10, 2012
March 15, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
8 months
Plasma concentrations of IPI-145 and metabolites
8 months
Study Arms (2)
IPI-145
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Gender : male or female
- Age : 18-55 years, inclusive
- Body Mass Index (BMI) : 18.0-30.0 kg/m2
- Medical history without major pathology
- 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
- 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)
- Willing and able to sign the written Informed Consent Form (ICF)
You may not qualify if:
- Previous participation in the current study
- Evidence of clinically relevant pathology
- History of relevant drug and/or food allergies
- Part 4 only: Known or suspected adverse reaction or contraindication to the imidazole class of drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SecuraBiolead
Study Sites (1)
PRA International
Zuidlaren, 9470 AE, Netherlands
MeSH Terms
Interventions
Study Officials
- STUDY CHAIR
Hagop Youssoufian, MD
Verastem, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2012
First Posted
March 8, 2012
Study Start
August 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
March 17, 2021
Record last verified: 2021-03