Healthy SubjectsPhase 1NCT03237988
Study to Evaluate the Pharmacokinetics of a New Tablet Formulation of CPI-444 in Fed and Fasted Healthy Male and Female Subjects
A Phase 1 study testing CPI-444 Capsules and CPI-444 Tablets in people with Healthy Subjects, run by Corvus Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- CPI-444 Capsules and CPI-444 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2017to 4 Oct 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Randomized, Single-dose, Three-way Crossover Study to Evaluate the Pharmacokinetics of a New Tablet Formulation of CPI-444 in Fed and Fasted Healthy Male and Female Subjects
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
- Being tested
- CPI-444 Capsules, CPI-444 Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPI-444 CapsulesDrug
100mg Capsule
CPI-444 TabletsDrug
100mg Tablets
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Drug: CPI-444 Capsules; Drug: CPI-444 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞: AUC from time zero to infinity
Area under the plasma concentration-time curve (AUC) from time zero to infinity
Measured: Predose through 72 hours postdose
AUC0-tz: AUC from time zero to last quantifiable concentration
AUC from time zero to the last quantifiable concentration
Measured: 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
Measured: Predose through 72 hours postdose
Secondary outcomes (1)
Incidence and severity of adverse events
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start20 Jul 2017
- Primary completion20 Sep 2017
- Study completion4 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corvus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237988
- Sponsor's protocol ID
- CPI-444-002
- Status last verified
- Jan 2018
- First submitted
- 25 Jul 2017
- Last updated
- 26 Jan 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, Single-dose, Three-way Crossover Study to Evaluate the Pharmacokinetics of a New Tablet Formulation of CPI-444 in Fed and Fasted Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT03237988
- Acronym / sponsor ID
- CPI-444-002
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Corvus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 20 Sep 2017 (actual)
- Study completion
- 4 Oct 2017 (actual)
- First posted
- 3 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence ABC | Active comparator | Drug: CPI-444 Capsules, Drug: CPI-444 Tablets100 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 BCA | Active comparator | Drug: CPI-444 Capsules, Drug: CPI-444 Tablets100 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 CAB | Active comparator | Drug: CPI-444 Capsules, Drug: CPI-444 Tablets100 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPI-444 Capsules100mg Capsule | Drug | Sequence ABC, Sequence BCA, Sequence CAB |
| CPI-444 Tablets100mg Tablets | Drug | Sequence ABC, Sequence BCA, Sequence CAB |
Primary outcome
AUC0-∞: AUC from time zero to infinity
Time frame: 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
Time frame: 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
Time frame: Predose through 72 hours postdose
Percentage of AUC0-∞ that was due to extrapolation from the last quantifiable concentration to infinity
1 secondary outcome
Incidence and severity of adverse events
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CPI-444 Capsules and CPI-444 Tablets in people with Healthy Subjects, run by Corvus Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-∞: AUC from time zero to infinity (time frame: Predose through 72 hours postdose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.