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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Infinity Pharmaceuticals, Inc.; SecuraBio
• Treatments: Ketoconazole

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