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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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)

ClinicalTrials.gov processed this record on September 22, 2014