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Olinciguat · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Healthy Volunteers | EXPERIMENTAL | Period 1: Single dose of olinciguat. Period 2: ITZ is dosed once daily (QD) for 10 days; a single dose of olinciguat is administered 1 hour after the fourth ITZ QD dose. |
| Healthy Male Volunteers | EXPERIMENTAL | Single oral dose of \[14C\]-olinciguat |
| Name | Type | Description |
|---|---|---|
| Olinciguat | DRUG | Oral Tablet |
| Itraconazole | DRUG | Oral Capsule |
| [14C]-olinciguat | DRUG | oral capsule |
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 reprodu...
Olinciguat is an investigational small molecule being studied in healthy volunteers. It is being developed by Cyclerion Therapeutics, Inc. (CYCN) and is currently in Phase 1 clinical development. The drug has been evaluated in clinical trials to study its absorption, metabolism, and excretion, as well as its interaction with other drugs.
Olinciguat is a soluble guanylate cyclase (sGC) stimulator. It works by stimulating sGC, an enzyme involved in the nitric oxide signaling pathway. This mechanism is being studied in early-phase clinical trials, though the drug is not yet approved for any condition.
Olinciguat is being developed by Cyclerion Therapeutics, Inc., a biopharmaceutical company traded under the ticker symbol CYCN. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers.
Olinciguat is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The completed Phase 1 trials focused on healthy volunteers to assess the drug's absorption, metabolism, excretion, and potential drug interactions.
Olinciguat has been studied in two completed Phase 1 clinical trials: NCT03795519, which examined the absorption, metabolism, and excretion of [14C]-Olinciguat in healthy male volunteers, and NCT03892499, which evaluated the effect of itraconazole, a CYP3A4 inhibitor, on the pharmacokinetics of Olinciguat in healthy volunteers.
Yes, Olinciguat is also known as IW-1701. In clinical trial NCT03892499, the drug is referred to as the soluble guanylate cyclase stimulator, Olinciguat (IW-1701). Both names refer to the same investigational compound being developed by Cyclerion Therapeutics.