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CPI-444

Phase 1

Healthy Subjects | Small molecule | Other |Corvus Pharmaceuticals, Inc.|Last Updated: Jan 26, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

CPI-444 · 1 trial · 1 indication

Phase 1 1
NCT03237988Study to Evaluate the Pharmacokinetics of a New Tablet Formulation of CPI-444 in Fed and Fasted Healthy Male and Female SubjectsHealthy Subjects
COMPLETED24 Analytics
PHASE1COMPLETED
Study to Evaluate the Pharmacokinetics of a New Tablet Formulation of CPI-444 in Fed and Fasted Healthy Male and Female Subjects
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

AUC0-∞: AUC from time zero to infinity
Predose through 72 hours postdose

Area under the plasma concentration-time curve (AUC) from time zero to infinity

AUC0-tz: AUC from time zero to last quantifiable concentration
Predose through 72 hours postdose

AUC from time zero to the last quantifiable concentration

%AUCex: Percentage of AUC0-∞ that was due to extrapolation from the last quantifiable concentration to infinity
Predose through 72 hours postdose

Percentage of AUC0-∞ that was due to extrapolation from the last quantifiable concentration to infinity

Secondary Endpoints

Incidence and severity of adverse events
4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Sequence ABCACTIVE_COMPARATOR100 mg CPI-444, given orally as a 1 × 100-mg capsule, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, 30 minutes after the start of a high-fat breakfast (fed).
Sequence BCAACTIVE_COMPARATOR100 mg CPI-444, given orally as a 1 × 100-mg tablet, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, 30 minutes after the start of a high-fat breakfast (fed); 100 mg CPI-444, given orally as a 1 × 100-mg capsule, after an overnight fast of at least 10 hours (fasted).
Sequence CABACTIVE_COMPARATOR100 mg CPI-444, given orally as a 1 × 100-mg tablet, 30 minutes after the start of a high-fat breakfast (fed); 100 mg CPI-444, given orally as a 1 × 100-mg capsule, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, after an overnight fast of at least 10 hours (fasted).

Interventions

NameTypeDescription
CPI-444 CapsulesDRUG100mg Capsule
CPI-444 TabletsDRUG100mg Tablets
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Males or females, of any race, 18 to 65 years of age, inclusive, at Screening. 2. Body mass index between 18.5 and 32.0 kg/m2, inclusive, at Screening. 3. In good health. 4. Females will be nonpregnant and nonlactating, and females of childbearing potential and males will agr...

Countries:United States
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Frequently asked questions about CPI-444

What is CPI-444 used for?

CPI-444 is an investigational small molecule being studied in healthy subjects. It is currently in Phase 1 clinical development. The drug is being evaluated for its pharmacokinetic profile, specifically how it is absorbed and processed by the body when taken as a tablet formulation.

Who makes CPI-444?

CPI-444 is being developed by Corvus Pharmaceuticals, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol CRVS. Corvus is conducting clinical trials to evaluate the drug's properties in healthy volunteers.

What phase is CPI-444 in?

CPI-444 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is currently being studied in a Phase 1 trial to evaluate its pharmacokinetics in healthy subjects.

What clinical trials is CPI-444 in?

CPI-444 has one completed clinical trial, identified as NCT03237988. This Phase 1 study evaluated the pharmacokinetics of a new tablet formulation of CPI-444 in fed and fasted healthy male and female subjects. The trial was conducted in the United States with 24 participants.

Is CPI-444 FDA approved?

CPI-444 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug is being studied in healthy subjects to evaluate its pharmacokinetic properties, but it has not yet received regulatory approval for any medical use.