A Study to Evaluate the Safety and Pharmacokinetics of CNTX-6016 in Healthy Subjects
1 other identifier
interventional
68
1 country
1
Brief Summary
A Phase 1 double-blind, placebo-controlled, randomized single ascending dose incorporating an open-label, 2-period crossover, food effect cohort.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 chronic-pain
Started Dec 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 26, 2019
CompletedFirst Submitted
Initial submission to the registry
October 7, 2019
CompletedFirst Posted
Study publicly available on registry
November 6, 2019
CompletedNovember 6, 2019
November 1, 2019
9 months
October 7, 2019
November 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (19)
Safety of single doses of CNTX-6016 - TEAEs
Information regarding treatment emergent adverse events was collected during each dose cohort.
Up to 80 days
Dose Proportionality of a single doses of CNTX-6016 in healthy subjects
Dose Proportionality of a single doses of CNTX-6016 in healthy subjects.
40 days
CNTX-6016 Pharmacokinetics - Cmax
Systemic exposure to CNTX-6016 measured by Cmax.
Up to 40 days
CNTX-6016 Pharmacokinetics - Tmax
Systemic exposure to CNTX-6016 measured by Tmax.
Up to 40 days
CNTX-6016 Pharmacokinetics - t1/2
Systemic exposure to CNTX-6016 measured by t1/2.
Up to 40 days
CNTX-6016 Pharmacokinetics - AUC 0-t
Systemic exposure to CNTX-6016 measured by AUC 0-t.
Up to 40 days
CNTX-6016 Pharmacokinetics - AUC 0-inf
Systemic exposure to CNTX-6016 measured by AUC 0-inf.
Up to 40 days
CNTX-6016 Pharmacokinetics - AUC 0-t/inf
Systemic exposure to CNTX-6016 measured by AUC 0-t/inf.
Up to 40 days
CNTX-6016 Pharmacokinetics - CL/F
Systemic exposure to CNTX-6016 measured by CL/F.
Up to 40 days
CNTX-6016 Pharmacokinetics - Vz/F
Systemic exposure to CNTX-6016 measured by Vz/F.
Up to 40 days
Effect of Gender on CNTX-6016 Pharmacokinetics - Cmax
Effect of Gender on the systemic exposure to CNTX-6016 measured by Cmax.
Up to 80 days
Effect of Gender on CNTX-6016 Pharmacokinetics - Tmax
Effect of Gender on the systemic exposure to CNTX-6016 measured by tmax.
Up to 80 days
Effect of Gender on CNTX-6016 Pharmacokinetics - t1/2
Effect of Gender on the systemic exposure to CNTX-6016 measured by t1/2
Up to 80 days
Effect of Gender on CNTX-6016 Pharmacokinetics - AUC
Effect of Gender on the systemic exposure to CNTX-6016 measured by AUC.
Up to 80 days
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Cmax
Systemic exposure to CNTX-6016 in fasted or fed state as measured by Cmax
Up to 40 days
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Tmax
Systemic exposure to CNTX-6016 in fasted or fed state as measured by Tmax
Up to 40 days
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - t1/2
Systemic exposure to CNTX-6016 in fasted or fed state as measured by t1/2
Up to 40 days
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - AUC
Systemic exposure to CNTX-6016 in fasted or fed state as measured by AUC
Up to 40 days
Urinary Excretion
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.
Up to 6 days
Secondary Outcomes (1)
Plasma and Urine Metabolite Mining
5 days
Study Arms (18)
Cohort 1 Placebo
PLACEBO COMPARATOROral Placebo Capsule
Cohort 1 Drug
EXPERIMENTAL25 mg Oral Capsule
Cohort 2 Placebo
PLACEBO COMPARATOROral Placebo Capsule
Cohort 2 Drug
EXPERIMENTAL50 mg Oral Capsule
Cohort 3 Placebo
PLACEBO COMPARATOROral Placebo Capsule
Cohort 3 Drug
EXPERIMENTAL100 mg Oral Capsule
Cohort 4 Placebo
PLACEBO COMPARATOROral Placebo Capsule
Cohort 4 Drug
EXPERIMENTAL300 mg Oral Capsule
Cohort 5 Placebo
PLACEBO COMPARATOROral Placebo Capsule
Cohort 5 Drug
EXPERIMENTAL450 mg Oral Capsule
Cohort 6 Placebo
PLACEBO COMPARATOROral Placebo Capsule
Cohort 6 Drug
EXPERIMENTAL600 mg Oral Capsule
Cohort 7 Placebo
PLACEBO COMPARATOROral Placebo Capsule
Cohort 7 Drug
EXPERIMENTAL800 mg Oral Capsule
Cohort 9 Placebo
PLACEBO COMPARATOROral Placebo Capsule
Cohort 9 Drug
EXPERIMENTAL1000 mg Oral Capsule
Cohort 8 Fasted
EXPERIMENTALParticipant will take 300 mg Oral Capsule in a fasting state, and then fed state.
Cohort 8 Fed
EXPERIMENTALParticipant will take 300 mg Oral Capsule in a fed state, and then fasting state.
Interventions
Oral Dose CNTX-6016
Oral Dose Placebo
Eligibility Criteria
You may qualify if:
- 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.
- For males, must agree to use barrier contraception and not to donate sperm.
You may not qualify if:
- History of or active cardiac disease, including congestive heart failure, angina, or any arrhythmia.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Altasciences Clinical Research
Overland Park, Kansas, 66212, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Randall M Stevens, MD
Centrexion Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2019
First Posted
November 6, 2019
Study Start
December 4, 2018
Primary Completion
August 21, 2019
Study Completion
August 26, 2019
Last Updated
November 6, 2019
Record last verified: 2019-11