IPI-145 Single Ascending, Multiple Ascending, Food Effect and Drug-Drug-Interaction Study
This study has been completed.
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc.
First received: February 10, 2012
Last updated: March 6, 2012
Last verified: March 2012
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.
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
||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
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- Plasma concentrations of IPI-145 and metabolites [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2012 (Final data collection date for primary outcome measure)
Single ascending dose up to 6 cohorts; multiple ascending dose up to 4 cohorts; food effect arm; ketoconazole drug interaction study
Placebo Comparator: Placebo
Single ascending dose up to 6 cohorts; multiple ascending dose up to 4 cohorts; food effect arm
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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)
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01549106
|Zuidlaren, Netherlands, 9470 AE |
Infinity Pharmaceuticals, Inc.
No publications provided
||Infinity Pharmaceuticals, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 10, 2012
||March 6, 2012
||Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 21, 2014
14-alpha Demethylase Inhibitors
Molecular Mechanisms of Pharmacological Action