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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01549106
First received: February 10, 2012
Last updated: March 6, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: IPI-145
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Infinity Pharmaceuticals, Inc.:

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 ]

Enrollment: 106
Study Start Date: August 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549106

Locations
Netherlands
PRA International
Zuidlaren, Netherlands, 9470 AE
Sponsors and Collaborators
Infinity Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01549106     History of Changes
Other Study ID Numbers: IPI-145-01, 2011-001944-31
Study First Received: February 10, 2012
Last Updated: March 6, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Ketoconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014