Recent Updates
Recently added Catalysts

praliciguat

Phase 1

Healthy Volunteers | Small molecule | Other |Cyclerion Therapeutics, Inc.|Last Updated: Jun 19, 2019

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

praliciguat · 1 trial · 1 indication

Phase 1 1
NCT03818295A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Praliciguat in Healthy Male VolunteersHealthy Volunteers
COMPLETED8 Analytics
PHASE1COMPLETED
A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Praliciguat in Healthy Male Volunteers
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Amount of total radioactivity excreted in urine (Aeu) and feces (Aef)
up to Day 15
Cumulative Aeu and cumulative Aef
up to Day 15
Percentage of total radioactivity excreted in urine (feu) and feces (fef)
up to Day 15
Cumulative feu and cumulative fef
up to Day 15
Percentage of total radioactivity in total excreta (feces + urine)
up to Day 15
Area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) of praliciguat in plasma
up to Day 15
AUC0-inf of total radioactivity in plasma and whole blood
up to Day 15
AUC from time zero to the last quantifiable concentration (AUC0-last) of praliciguat in plasma
up to Day 15
AUC0-last of total radioactivity in plasma and whole blood
up to Day 15
Maximum observed concentration (Cmax) of praliciguat in plasma
up to Day 15
Cmax of total radioactivity in plasma and whole blood
up to Day 15
Time of Cmax (Tmax) of praliciguat in plasma
up to Day 15
Tmax of total radioactivity in plasma and whole blood
up to Day 15
Apparent terminal elimination half-life (t1/2) of praliciguat in plasma
up to Day 15
t1/2 total radioactivity in plasma and whole blood
up to Day 15
Apparent total clearance of praliciguat (CL/F)
up to Day 15
Apparent volume of distribution of praliciguat (Vz/F)
up to Day 15
AUC0-inf of plasma praliciguat concentration relative to AUC0-inf of plasma total radioactivity (AUC0-inf Ratio of Plasma Praliciguat/Plasma Total Radioactivity)
up to Day 15
AUC0-inf of whole blood total radioactivity to AUC0-inf of plasma total radioactivity (AUC0-inf Ratio of Blood Total Radioactivity/Plasma Total Radioactivity)
up to Day 15

Secondary Endpoints

Levels of metabolite radioactivity excreted in urine and feces
up to Day 15
AUC0-inf of metabolite radioactivity levels in plasma
up to Day 15
AUC0-inf of plasma metabolite radioactivity levels relative to AUC0-inf of plasma total radioactivity (Plasma AUC0-inf Ratio of Metabolite Radioactivity/Total Radioactivity)
up to Day 15
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
Healthy Male VolunteersEXPERIMENTALSingle oral dose of \[14C\]-praliciguat

Interventions

NameTypeDescription
[14C]-praliciguatDRUG10 mg praliciguat containing approximately 500 μCi of \[14C\]-praliciguat
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Males of any race, between 18 and 55 years of age, inclusive * Body mass index between 18 and 32 kg/m2, inclusive * Subject is in good health and has no clinically significant findings on physical examination * Men must agree to use protocol-specified contraception and also to...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about praliciguat

What is praliciguat?

Praliciguat is an investigational small molecule being developed by Cyclerion Therapeutics, Inc. (CYCN). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, with one completed trial involving 8 participants.

What is praliciguat used for?

Praliciguat is being studied for use in healthy volunteers. It is an investigational drug in Phase 1 clinical development, meaning it has not been approved for any medical condition. The completed trial focused on healthy male volunteers to study the drug's absorption, metabolism, and excretion.

Who makes praliciguat?

Praliciguat is developed by Cyclerion Therapeutics, Inc., a biopharmaceutical company traded under the ticker symbol CYCN. The company is conducting clinical research on this investigational small molecule drug.

What phase is praliciguat in?

Praliciguat is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and there are no active trials currently listed for this drug.

What clinical trials is praliciguat in?

Praliciguat has one completed clinical trial, NCT03818295, titled "A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Praliciguat in Healthy Male Volunteers." This Phase 1 study enrolled 8 healthy male participants in the United States and was not randomized or blinded.