A Trial to Evaluate the Effect of Itraconazole (ITZ), a CYP3A4 Inhibitor, on the Pharmacokinetics of the Soluble Guanylate Cyclase Stimulator, Olinciguat (IW-1701), in Healthy Volunteers
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/5/2019 |
| Start Date: | April 2019 |
| End Date: | June 2019 |
| Contact: | Kyle Herbert |
| Email: | Kherbert@cyclerion.com |
| Phone: | 978.995.4951 |
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 Olinciguat (IW-1701)
To evaluate the effect of itraconazole (a potent cytochrome P450 isoenzyme [CYP]3A inhibitor)
on the pharmacokinetics (PK) of olinciguat
on the pharmacokinetics (PK) of olinciguat
Inclusion Criteria:
- Subject is an ambulatory adult and between 18 and 55 years old (inclusive) 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 kg/m2 at the screening visit
- Women of reproductive potential must have a negative pregnancy test at screening at at
the time of check-in and must agree to use protocol-specified contraception throughout
the duration of the study and until 90 days after receiving the final study drug dose
- Men must agree to use protocol-specified contraception and also to not donate sperm
throughout the study and until 90 days after receiving the final study drug dose
- Other inclusion criteria per protocol
Exclusion Criteria:
- Any active or unstable clinically significant medical condition
- Use of any prescribed or non-prescribed medication (except for hormonal birth control)
- Other exclusion criteria per protocol
We found this trial at
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