Study to Evaluate the Pharmacokinetics of a New Tablet Formulation of CPI-444 in Fed and Fasted Healthy Male and Female Subjects

NCT03237988 | Completed Phase 1 FDA Drug

• 1 other identifier: CPI-444-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 doses of CPI-444 tablets in healthy male and female subjects. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the first dose administration.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• AUC0-∞: AUC from time zero to infinity

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

  Predose through 72 hours postdose

• AUC0-tz: AUC from time zero to last quantifiable concentration

  AUC from time zero to the last quantifiable concentration

  Predose through 72 hours postdose

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

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

  Predose through 72 hours postdose

Secondary Outcomes (1)

• Incidence and severity of adverse events

  4 weeks

Study Arms (3)

Sequence ABC

ACTIVE COMPARATOR

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); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, 30 minutes after the start of a high-fat breakfast (fed).

Drug: CPI-444 Capsules; Drug: CPI-444 Tablets

Sequence BCA

ACTIVE COMPARATOR

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); 100 mg CPI-444, given orally as a 1 × 100-mg capsule, after an overnight fast of at least 10 hours (fasted).

Drug: CPI-444 Capsules; Drug: CPI-444 Tablets

Sequence CAB

ACTIVE COMPARATOR

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); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, after an overnight fast of at least 10 hours (fasted).

Drug: CPI-444 Capsules; Drug: CPI-444 Tablets

Interventions

CPI-444 Capsules DRUG

100mg Capsule

Sequence ABC; Sequence BCA; Sequence CAB

CPI-444 Tablets DRUG

100mg Tablets

Sequence ABC; Sequence BCA; Sequence CAB

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Corvus Pharmaceuticals, Inc.: lead

Study Sites (1)

Covance Clinical Research Unit

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

ciforadenant

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: August 3, 2017
• Study Start: July 20, 2017
• Primary Completion: September 20, 2017
• Study Completion: October 4, 2017
• Last Updated: January 26, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)