Clinical trial NCT03499106: A Trial to Evaluate the Effect of Itraconazole (ITZ), a CYP3A4 Inhibitor, on the Pharmacokinetics of Praliciguat (IW-1973) in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Cyclerion Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-04-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Plasma Concentration Time Curve of IW-1973 From Time Zero Extrapolated to Infinity (AUC[0-inf])
timeFrame: Predose and up to 14 days post dose of IW-1973
measure: Maximum Observed Plasma Concentration (Cmax) of IW-1973
timeFrame: Predose and up to 14 days post dose of IW-1973
Secondary outcomes:
measure: Time to Cmax (Tmax) of IW-1973
timeFrame: Predose and up to 14 days post dose of IW-1973
measure: Area Under the Concentration-Time Curve From Time Zero to 24 hours AUC(0-24) Postdose of IW-1973
timeFrame: Predose and up to 14 days post dose of IW-1973
measure: Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC[0-last]) of IW-1973
timeFrame: Predose and up to 14 days post dose of IW-1973
measure: Apparent Terminal Half-Life (t1/2) of IW-1973
timeFrame: Predose and up to 14 days post dose of IW-1973
measure: Apparent Terminal Rate Constant (lambda[z]) of IW-1973
timeFrame: Predose and up to 14 days post dose of IW-1973
measure: Apparent Total Plasma Clearance (CL/F) of IW-1973
timeFrame: Predose and up to 14 days post dose of IW-1973
measure: Apparent Volume of Distribution (Vz/F) of IW-1973
timeFrame: Predose and up to 14 days post dose of IW-1973
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: IQVIA
state: Kansas
Study officials:
References: