A Trial to Evaluate the Effect of Itraconazole (ITZ), a CYP3A4 Inhibitor, on the Pharmacokinetics of Praliciguat (IW-1973) in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/5/2019 |
| Start Date: | April 12, 2018 |
| End Date: | July 6, 2018 |
An Open-label, 2-Period, Fixed-sequence, Phase 1 Study in Healthy Volunteers to Evaluate the Effect of Itraconazole, a Potent CYP3A Inhibitor, on the Pharmacokinetics of IW-1973
The primary objective of the study is to evaluate the effect of itraconazole (a potent
cytochrome P450 isoenzyme [CYP]3A inhibitor) on the pharmacokinetics of IW-1973.
cytochrome P450 isoenzyme [CYP]3A inhibitor) on the pharmacokinetics of IW-1973.
Inclusion Criteria:
- Subject is an ambulatory adult between 18 and 75 years old at the screening visit
- Subject is in good health and has no clinically significant findings on physical
examination
- Body mass index is > 18 and < 30.0 kg/m2 at the screening visit
- Women of reproductive potential must have a negative pregnancy test at the time of
check-in and must agree to use protocol-specified contraception throughout the
duration of the study and for 2 months after the final dose of study drug
- Men must agree to use protocol-specified contraception and also to not donate sperm
throughout the study and for 2 months after the final dose of study drug
- Other inclusion criteria per protocol
Exclusion Criteria:
- Any active or unstable clinically significant medical condition
- Use of any prescribed or non-prescribed medication
- Other exclusion criteria per protocol
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