Phase 1 Study in Healthy Subjects to Evaluate the Effect of Rifampin on the Pharmacokinetics of IPI-145
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 11/23/2013 |
| Start Date: | October 2013 |
| End Date: | December 2013 |
| Contact: | Musa Mutyaba |
| Email: | Musa.Mutyaba@infi.com |
| Phone: | 617-453-1320 |
A Phase 1, Open-Label, Single-Sequence, 2-Period Study to Evaluate the Effect of Rifampin (a CYP3A Inducer) on the Pharmacokinetics of IPI-145 in Healthy Subjects
To evaluate the effect of rifampin, a cytochrome P450 3A (CYP3A) inducer, on the
pharmacokinetics (PK) of IPI-145; to assess the safety and tolerability of IPI-145 when
administered with rifampin in healthy subjects
- In Treatment Period 1, subjects will receive a single 25 mg oral dose of IPI-145
- In Treatment Period 2, on Days 3-9, the same subjects will receive once daily (QD) oral
doses of 600 mg rifampin; on Day 9, subjects will receive a single oral dose of 25 mg
IPI-145 concomitantly administered with 600 mg of rifampin
Inclusion Criteria:
- Healthy men or women of non-childbearing potential between 18-50 years of age
- Body Mass Index (BMI): 18.0 - 32.0 kg/m2
- In good health, determined by no clinically significant findings from clinical
evaluations
- Provided written informed consent prior to any study specific procedures
Exclusion Criteria:
- Women of childbearing potential
- Evidence of clinically significant medical conditions
- History of gastrointestinal disease or surgery that may affect drug absorption
- Positive or indeterminate Tuberculosis -spot test at screening
- Any active infection at the time of screening or admission
- Consumption of any nutrients known to modulate cytochrome P450 enzyme activity within
14 days prior to administration of study drug, during the study, and until after
discharge
We found this trial at
1
site
Click here to add this to my saved trials
