A Study to Evaluate the Safety and Pharmacokinetics of CNTX-6016 in Healthy Subjects
NCT ID: NCT04154501
Last Updated: 2019-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
68 participants
INTERVENTIONAL
2018-12-04
2019-08-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Cohort 1 Placebo
Oral Placebo Capsule
Other: Placebo
Oral Dose Placebo
Cohort 1 Drug
25 mg Oral Capsule
CNTX-6016
Oral Dose CNTX-6016
Cohort 2 Placebo
Oral Placebo Capsule
Other: Placebo
Oral Dose Placebo
Cohort 2 Drug
50 mg Oral Capsule
CNTX-6016
Oral Dose CNTX-6016
Cohort 3 Placebo
Oral Placebo Capsule
Other: Placebo
Oral Dose Placebo
Cohort 3 Drug
100 mg Oral Capsule
CNTX-6016
Oral Dose CNTX-6016
Cohort 4 Placebo
Oral Placebo Capsule
Other: Placebo
Oral Dose Placebo
Cohort 4 Drug
300 mg Oral Capsule
CNTX-6016
Oral Dose CNTX-6016
Cohort 5 Placebo
Oral Placebo Capsule
Other: Placebo
Oral Dose Placebo
Cohort 5 Drug
450 mg Oral Capsule
CNTX-6016
Oral Dose CNTX-6016
Cohort 6 Placebo
Oral Placebo Capsule
Other: Placebo
Oral Dose Placebo
Cohort 6 Drug
600 mg Oral Capsule
CNTX-6016
Oral Dose CNTX-6016
Cohort 7 Placebo
Oral Placebo Capsule
Other: Placebo
Oral Dose Placebo
Cohort 7 Drug
800 mg Oral Capsule
CNTX-6016
Oral Dose CNTX-6016
Cohort 9 Placebo
Oral Placebo Capsule
Other: Placebo
Oral Dose Placebo
Cohort 9 Drug
1000 mg Oral Capsule
CNTX-6016
Oral Dose CNTX-6016
Cohort 8 Fasted
Participant will take 300 mg Oral Capsule in a fasting state, and then fed state.
CNTX-6016
Oral Dose CNTX-6016
Cohort 8 Fed
Participant will take 300 mg Oral Capsule in a fed state, and then fasting state.
CNTX-6016
Oral Dose CNTX-6016
Interventions
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CNTX-6016
Oral Dose CNTX-6016
Other: Placebo
Oral Dose Placebo
Eligibility Criteria
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Inclusion Criteria
* Has a body mass index (BMI) between 18 and 35 kg/m2.
* Non- or ex-smoker (\> 1 year) and has not used any nicotine containing products within 12 months prior to screening.
* For females, is not currently pregnant and is either of non-childbearing potential or willing to use an adequate method of birth control.
* For males, must agree to use barrier contraception and not to donate sperm.
Exclusion Criteria
* Has any history or currently active type of cancer except excised or cured basal cell carcinoma.
* Has a gastrointestinal disorder that could interfere with the absorption of orally administered drugs.
* Has asthma or other severe respiratory disease (e.g., chronic obstructive pulmonary disease) requiring daily prescription medicine.
* Currently has kidney, neurologic, metabolic, or liver disease, or other organ system disease.
* Has a history, current evidence, or is being treated for depression, suicidal ideation, suicide attempt, or any other current psychiatric condition requiring active treatment.
* Has an immunological disorder such as, but not limited to, human immunodeficiency virus (HIV), acquired, or congenital immune deficiency syndrome; autoimmune diseases, such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, seronegative spondyloarthropathies or vasculitis, or any infection.
* Has positive screening test for hepatitis B virus (HBV) or hepatitis C virus (HCV).
* Is pregnant, lactating, or planning a pregnancy during the study.
* Has used any prescribed medication within 30 days prior to the first admission or has plans to use any prescribed medication during the study (with the exception of hormonal contraceptives).
* Positive urine screen for alcohol, cotinine, THC and/or drugs of abuse.
* Ingestion of food or beverages containing grapefruit and/or grapefruit juice and/or pomelos during the 7 days prior to dosing and/or during the study period.
18 Years
55 Years
ALL
Yes
Sponsors
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Centrexion Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Randall M Stevens, MD
Role: STUDY_CHAIR
Centrexion Therapeutics
Locations
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Altasciences Clinical Research
Overland Park, Kansas, United States
Countries
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Other Identifiers
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CNTX-6016o-HV-101
Identifier Type: -
Identifier Source: org_study_id
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