Status:
COMPLETED
Study to Evaluate the Pharmacokinetics of a New Tablet Formulation of CPI-444 in Fed and Fasted Healthy Male and Female Subjects
Lead Sponsor:
Corvus Pharmaceuticals, Inc.
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This will be a Phase 1, open-label, randomized, 3-way crossover study to evaluate PK, safety, and tolerability of a new tablet formulation of CPI-444 and to evaluate the effect of food on single oral ...
Eligibility Criteria
Inclusion
- Males or females, of any race, 18 to 65 years of age, inclusive, at Screening.
- Body mass index between 18.5 and 32.0 kg/m2, inclusive, at Screening.
- In good health.
- Females will be nonpregnant and nonlactating, and females of childbearing potential and males will agree to use contraception.
- Able to comprehend and willing to sign an Informed Consent Form (ICF) and to abide by the study restrictions.
Exclusion
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder.
- Subjects who have received any IMP in a clinical research study within 5 half-lives or within 30 days prior to first dose.
- Females of childbearing potential who are pregnant or lactating. Females of non-childbearing potential are defined as permanently sterile or postmenopausal. Postmenopausal status will be confirmed with a screening serum follicle-stimulating hormone (FSH) level greater than 40 mIU/mL.
- A history or evidence of clinically significant gastrointestinal disease, including ulcers, gastro-esophageal reflux disease, or gastritis.
- A history of alcoholism or drug/chemical abuse within 2 years prior to Period 1 Check-in.
- Regular alcohol consumption of \>21 units per week for males and \>14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
- Positive urine drug screen (confirmed by repeat) at Screening (does not include alcohol) or Check-in (does include alcohol).
- Use of prescription or nonprescription drugs, including vitamins, herbal, and dietary supplements (ie, St John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of IMP.
- Use of tobacco, smoking cessation products, or products containing nicotine (including, but not limited to, cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine lozenges, or nicotine gum) within 6 months prior to Period 1 Check-in until Discharge from the CRU following the final dose.
- Consumption of foods and beverages containing poppy seeds, grapefruit, or Seville oranges will not be allowed from 7 days prior to Period 1 Check-in until Discharge from the CRU following the final dose.
- Consumption of caffeine-containing foods and beverages will not be allowed from 72 hours prior to Check-in until Discharge on Day 4 of each treatment period.
- Poor peripheral venous access.
- Evidence of renal impairment at Screening, as indicated by an estimated creatinine clearance of less than 80 mL/min using the Cockcroft-Gault equation.
- Screening chemistry laboratory values as follows: gamma-glutamyltransferase, aspartate aminotransferase, and ALT \>1.5 × institutional upper limit of normal (ULN), total bilirubin \>1.5 × institutional ULN.
- A history of seizures (not including simple febrile seizures in childhood);
- Multiple drug allergies or allergies to any of the components of CPI-444 tablets or CPI 444 resinate capsules.
- Known history of human immunodeficiency virus or active infection requiring therapy, or positive tests for hepatitis B surface antigen or hepatitis C antibody.
- Any vaccination against infectious diseases (ie, influenza, varicella) within 28 days of first dose.
- Donation or loss of greater than 400 mL of blood from 2 months prior to Screening, donation of platelets from 6 weeks prior to Screening, or plasma from 2 weeks prior to Screening through the Follow-up phone call.
- Receipt of blood products within 2 months prior to Period 1 Check-in.
- Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
Key Trial Info
Start Date :
July 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2017
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03237988
Start Date
July 20 2017
End Date
October 4 2017
Last Update
January 26 2018
Active Locations (1)
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1
Covance Clinical Research Unit
Dallas, Texas, United States, 75247