Phase 1 Study in Healthy Subjects to Evaluate the Effect of IPI-145 on the Pharmacokinetics of Midazolam

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01925911

Run by

SecuraBio

People needed

14

Starts

2013-08-01

Expected to finish

2013-10-01

Last updated by the study team

2021-03-17

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• PRA International — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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