Phase 1 Study in Healthy Subjects to Evaluate the Effect of IPI-145 on the Pharmacokinetics of Midazolam
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 10/18/2018 |
| Start Date: | August 2013 |
| End Date: | October 2013 |
A Phase 1, Open-Label, Single-Sequence, 2-Period Study to Evaluate the Effect of IPI-145 on Single-Dose Pharmacokinetics of Midazolam (a CYP3A Substrate) in Healthy Subjects
To evaluate the effect of IPI-145 on the pharmacokinetics of midazolam, a cytochrome P450 3A
(CYP3A) substrate; to assess the safety and tolerability of IPI-145 when administered with
midazolam in healthy subjects.
(CYP3A) substrate; to assess the safety and tolerability of IPI-145 when administered with
midazolam in healthy subjects.
- In Treatment Period 1, subjects will receive a single 2 mg oral dose of midazolam.
- In Treatment Period 2, on Days 2-6, the same subjects will receive twice daily (BID)
oral doses of 25 mg IPI-145; on Day 6, subjects will receive the morning dose of 25 mg
IPI-145 concomitantly administered with 2 mg of midazolam.
- In Treatment Period 2, on Days 2-6, the same subjects will receive twice daily (BID)
oral doses of 25 mg IPI-145; on Day 6, subjects will receive the morning dose of 25 mg
IPI-145 concomitantly administered with 2 mg of midazolam.
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
- Subjects with acute narrow-angle glaucoma
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