A Trial to Evaluate the Effect of Itraconazole (ITZ), a CYP3A4 Inhibitor, on the Pharmacokinetics of Praliciguat (IW-1973) in Healthy Volunteers

• Sponsor: Cyclerion Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03499106
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.8
• Patients Per Site Per Month: 8.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: IW-1973; Drug: Itraconazole	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: 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
• Actual Study Start Date: Apr 12, 2018
• Actual Primary Completion Date: Jul 6, 2018
• Actual Study Completion Date: Jul 6, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy Volunteers Period 1: Single dose of IW-1973. Period 2: ITZ is dosed once daily (QD) for 17 days; a single dose of IW-1973 is administered 1 hour after the fourth ITZ QD dose.	Drug: IW-1973; Oral Tablet; Drug: Itraconazole; Oral Capsule

Outcome Measures

Primary Outcome Measures

1. Area Under the Plasma Concentration Time Curve of IW-1973 From Time Zero Extrapolated to Infinity (AUC[0-inf]) [Predose and up to 14 days post dose of IW-1973]

2. Maximum Observed Plasma Concentration (Cmax) of IW-1973 [Predose and up to 14 days post dose of IW-1973]

Secondary Outcome Measures

1. Time to Cmax (Tmax) of IW-1973 [Predose and up to 14 days post dose of IW-1973]

2. Area Under the Concentration-Time Curve From Time Zero to 24 hours AUC(0-24) Postdose of IW-1973 [Predose and up to 14 days post dose of IW-1973]

3. Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC[0-last]) of IW-1973 [Predose and up to 14 days post dose of IW-1973]

4. Apparent Terminal Half-Life (t1/2) of IW-1973 [Predose and up to 14 days post dose of IW-1973]

5. Apparent Terminal Rate Constant (lambda[z]) of IW-1973 [Predose and up to 14 days post dose of IW-1973]

6. Apparent Total Plasma Clearance (CL/F) of IW-1973 [Predose and up to 14 days post dose of IW-1973]

7. Apparent Volume of Distribution (Vz/F) of IW-1973 [Predose and up to 14 days post dose of IW-1973]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IQVIA	Overland Park	Kansas	United States	66211

Sponsors and Collaborators

• Cyclerion Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cyclerion Therapeutics
• ClinicalTrials.gov Identifier: NCT03499106
• Other Study ID Numbers: C1973-104
• First Posted: Apr 17, 2018
• Last Update Posted: Apr 3, 2019
• Last Verified: Apr 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Itraconazole; Praliciguat

Study Results

No Results Posted as of Apr 3, 2019