CClinicalTrials.gg
Sign In
CompletedNCT03892499Updated Jul 15, 2019

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

A Phase 1 interventional study of Olinciguat and Itraconazole in Healthy, sponsored by Cyclerion Therapeutics. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-15.

Sponsored by Cyclerion Therapeutics · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

To evaluate the effect of itraconazole (a potent cytochrome P450 isoenzyme [CYP]3A inhibitor) on the pharmacokinetics (PK) of olinciguat

02

Conditions studied

  • Healthy
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Healthy Volunteers

    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.

    Drug: Olinciguat · Drug: Itraconazole

Interventions

  • DrugOlinciguat

    Oral Tablet

    Also known as: IW-1701

  • DrugItraconazole

    Oral Capsule

05

What researchers measure

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of olinciguat

    Time frame: Predose and up to 8 days post first olinciguat dose

  2. Area under the plasma concentration time curve from time zero (predose) extrapolated to infinity (AUCinf)

    Time frame: Predose and up to 8 days post first olinciguat dose

Secondary outcomes

  1. Number of subjects with ≥1 treatment-emergent adverse event (TEAE) in Period 1 vs Period 2

    Time frame: 51 days post first olinciguat dose

  2. Cmax of Itraconazole

    Time frame: First Itraconazole dose up to day 8 of Period 2 (Period 2 duration can be up to 13 days)

  3. Area under the concentration-time curve during a dosing interval (AUCtau) for itraconazole and hydroxy-itraconazole

    Time frame: Period 2 (Period 2 duration can be up to 13 days) predose and up to 24 hour after 2nd olinciguat dose

  4. Cmax of hydroxy-Itraconazole

    Time frame: First Itraconazole dose up to day 8 of Period 2 (Period 2 duration can be up to 13 days)

06

Study locations

1 site
  • PPD
    Austin, Texas 78744, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03892499
Lead sponsor
Cyclerion Therapeutics
Responsible party
Sponsor
First posted
Mar 27, 2019
Start date
May 3, 2019
Primary completion
Jun 23, 2019
Completion
Jul 3, 2019
Last update
Jul 15, 2019

Study contacts

Bina Tejura, MD
study director · Cyclerion Therapeutics

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Cyclerion Therapeutics

Start the discussion