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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03499106
• Other study ID #: C1973-104
• Status: Completed
• Phase: Phase 1
• Start date: April 12, 2018
• Est. completion date: July 6, 2018

Study information

• Verified date: April 2019
• Source: Cyclerion Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 6, 2018
• Est. primary completion date: July 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• IW-1973
Oral Tablet
• Itraconazole
Oral Capsule

Locations

Country	Name	City	State
United States	IQVIA	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Cyclerion Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum Observed Plasma Concentration (Cmax) of IW-1973		Predose and up to 14 days post dose of IW-1973
Secondary	Time to Cmax (Tmax) of IW-1973		Predose and up to 14 days post dose of IW-1973
Secondary	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
Secondary	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
Secondary	Apparent Terminal Half-Life (t1/2) of IW-1973		Predose and up to 14 days post dose of IW-1973
Secondary	Apparent Terminal Rate Constant (lambda[z]) of IW-1973		Predose and up to 14 days post dose of IW-1973
Secondary	Apparent Total Plasma Clearance (CL/F) of IW-1973		Predose and up to 14 days post dose of IW-1973
Secondary	Apparent Volume of Distribution (Vz/F) of IW-1973		Predose and up to 14 days post dose of IW-1973