A Study to Evaluate the Safety and Pharmacokinetics of CNTX-6016 in Healthy Subjects
Study Details
Study Description
Brief Summary
A Phase 1 double-blind, placebo-controlled, randomized single ascending dose incorporating an open-label, 2-period crossover, food effect cohort.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Placebo Comparator: Cohort 1 Placebo Oral Placebo Capsule |
Other: Other: Placebo
Oral Dose Placebo
|
Experimental: Cohort 1 Drug 25 mg Oral Capsule |
Drug: CNTX-6016
Oral Dose CNTX-6016
|
Placebo Comparator: Cohort 2 Placebo Oral Placebo Capsule |
Other: Other: Placebo
Oral Dose Placebo
|
Experimental: Cohort 2 Drug 50 mg Oral Capsule |
Drug: CNTX-6016
Oral Dose CNTX-6016
|
Placebo Comparator: Cohort 3 Placebo Oral Placebo Capsule |
Other: Other: Placebo
Oral Dose Placebo
|
Experimental: Cohort 3 Drug 100 mg Oral Capsule |
Drug: CNTX-6016
Oral Dose CNTX-6016
|
Placebo Comparator: Cohort 4 Placebo Oral Placebo Capsule |
Other: Other: Placebo
Oral Dose Placebo
|
Experimental: Cohort 4 Drug 300 mg Oral Capsule |
Drug: CNTX-6016
Oral Dose CNTX-6016
|
Placebo Comparator: Cohort 5 Placebo Oral Placebo Capsule |
Other: Other: Placebo
Oral Dose Placebo
|
Experimental: Cohort 5 Drug 450 mg Oral Capsule |
Drug: CNTX-6016
Oral Dose CNTX-6016
|
Placebo Comparator: Cohort 6 Placebo Oral Placebo Capsule |
Other: Other: Placebo
Oral Dose Placebo
|
Experimental: Cohort 6 Drug 600 mg Oral Capsule |
Drug: CNTX-6016
Oral Dose CNTX-6016
|
Placebo Comparator: Cohort 7 Placebo Oral Placebo Capsule |
Other: Other: Placebo
Oral Dose Placebo
|
Experimental: Cohort 7 Drug 800 mg Oral Capsule |
Drug: CNTX-6016
Oral Dose CNTX-6016
|
Placebo Comparator: Cohort 9 Placebo Oral Placebo Capsule |
Other: Other: Placebo
Oral Dose Placebo
|
Experimental: Cohort 9 Drug 1000 mg Oral Capsule |
Drug: CNTX-6016
Oral Dose CNTX-6016
|
Experimental: Cohort 8 Fasted Participant will take 300 mg Oral Capsule in a fasting state, and then fed state. |
Drug: CNTX-6016
Oral Dose CNTX-6016
|
Experimental: Cohort 8 Fed Participant will take 300 mg Oral Capsule in a fed state, and then fasting state. |
Drug: CNTX-6016
Oral Dose CNTX-6016
|
Outcome Measures
Primary Outcome Measures
- Safety of single doses of CNTX-6016 - TEAEs [Up to 80 days]
Information regarding treatment emergent adverse events was collected during each dose cohort.
- Dose Proportionality of a single doses of CNTX-6016 in healthy subjects [40 days]
Dose Proportionality of a single doses of CNTX-6016 in healthy subjects.
- CNTX-6016 Pharmacokinetics - Cmax [Up to 40 days]
Systemic exposure to CNTX-6016 measured by Cmax.
- CNTX-6016 Pharmacokinetics - Tmax [Up to 40 days]
Systemic exposure to CNTX-6016 measured by Tmax.
- CNTX-6016 Pharmacokinetics - t1/2 [Up to 40 days]
Systemic exposure to CNTX-6016 measured by t1/2.
- CNTX-6016 Pharmacokinetics - AUC 0-t [Up to 40 days]
Systemic exposure to CNTX-6016 measured by AUC 0-t.
- CNTX-6016 Pharmacokinetics - AUC 0-inf [Up to 40 days]
Systemic exposure to CNTX-6016 measured by AUC 0-inf.
- CNTX-6016 Pharmacokinetics - AUC 0-t/inf [Up to 40 days]
Systemic exposure to CNTX-6016 measured by AUC 0-t/inf.
- CNTX-6016 Pharmacokinetics - CL/F [Up to 40 days]
Systemic exposure to CNTX-6016 measured by CL/F.
- CNTX-6016 Pharmacokinetics - Vz/F [Up to 40 days]
Systemic exposure to CNTX-6016 measured by Vz/F.
- Effect of Gender on CNTX-6016 Pharmacokinetics - Cmax [Up to 80 days]
Effect of Gender on the systemic exposure to CNTX-6016 measured by Cmax.
- Effect of Gender on CNTX-6016 Pharmacokinetics - Tmax [Up to 80 days]
Effect of Gender on the systemic exposure to CNTX-6016 measured by tmax.
- Effect of Gender on CNTX-6016 Pharmacokinetics - t1/2 [Up to 80 days]
Effect of Gender on the systemic exposure to CNTX-6016 measured by t1/2
- Effect of Gender on CNTX-6016 Pharmacokinetics - AUC [Up to 80 days]
Effect of Gender on the systemic exposure to CNTX-6016 measured by AUC.
- Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Cmax [Up to 40 days]
Systemic exposure to CNTX-6016 in fasted or fed state as measured by Cmax
- Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Tmax [Up to 40 days]
Systemic exposure to CNTX-6016 in fasted or fed state as measured by Tmax
- Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - t1/2 [Up to 40 days]
Systemic exposure to CNTX-6016 in fasted or fed state as measured by t1/2
- Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - AUC [Up to 40 days]
Systemic exposure to CNTX-6016 in fasted or fed state as measured by AUC
- Urinary Excretion [Up to 6 days]
Urine was collected over a 3-day period (0-72 hrs) in Cohort 8 and analyzed for concentrations of CNTX-6016 in subjects in both the fasted and fed states using Liquid Chromatography Mass Spectrometry.
Secondary Outcome Measures
- Plasma and Urine Metabolite Mining [5 days]
Urine was collected over a 3-day period (0-72hrs) in Cohort 9 (1000mg) and analyzed for concentrations of parent and metabolites of CNTX-6016 using Liquid Chromatography Mass Spectrometry.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
Is in good general health as determined by Investigator's review.
-
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.
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For males, must agree to use barrier contraception and not to donate sperm.
Key Exclusion Criteria:
-
History of or active cardiac disease, including congestive heart failure, angina, or any arrhythmia.
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Has any history or currently active type of cancer except excised or cured basal cell carcinoma.
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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.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Altasciences Clinical Research | Overland Park | Kansas | United States | 66212 |
Sponsors and Collaborators
- Centrexion Therapeutics
Investigators
- Study Chair: Randall M Stevens, MD, Centrexion Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CNTX-6016o-HV-101