A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CNTX-6016 in Healthy Subjects and a Single Cohort of Subjects With Painful Diabetic Neuropathy
Overview
- Phase
- Phase 1
- Intervention
- Oral dose CNTX-6016 or oral dose Placebo
- Conditions
- Painful Diabetic Neuropathy
- Sponsor
- Centrexion Therapeutics
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- CNTX-6016 Pharmacokinetics - t1/2
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief Summary
A Phase 1b study to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of CNTX-6016 in healthy subjects and a single cohort to evaluate painful diabetic neuropathy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Is in good general health as determined by Investigator's review.
- •Has a body mass index (BMI) between 18 and 35 kg/m
- •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
- •Is pregnant, lactating, or planning a pregnancy during the study.
- •Tests positive for COVID-19 after screening is complete and subject is confirmed to enroll
- •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 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.
- •Positive urine screen for alcohol, cotinine, THC and/or drugs of abuse
- •Has positive screening test for hepatitis B virus (HBV) or hepatitis C virus (HCV).
- •Key Inclusion Criteria- PDN Cohort
- •A diagnosis/history of Type 2 diabetes mellitus
- •The pain is present in both feet/legs with symmetrical onset
Arms & Interventions
Cohort 1
Dose 1
Intervention: Oral dose CNTX-6016 or oral dose Placebo
Cohort 2
Dose 2
Intervention: Oral dose CNTX-6016 or oral dose Placebo
Cohort 3
Dose 3
Intervention: Oral dose CNTX-6016 or oral dose Placebo
PDN cohort
Dose based on safety in healthy Cohorts 1-3
Intervention: Oral dose CNTX-6016 or oral dose Placebo
Outcomes
Primary Outcomes
CNTX-6016 Pharmacokinetics - t1/2
Time Frame: Up to Day 6
Systemic exposure to CNTX-6016 measured by t1/2
Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability) with CNTX-6016
Time Frame: Up to 45 days
Number of participants with TEAEs, which includes laboratory test variables
CNTX-6016 Pharmacokinetics - Cmax
Time Frame: Up to Day 6
Systemic exposure to CNTX-6016 measured by Cmax
CNTX-6016 Pharmacokinetics - AUC0-t
Time Frame: Up to Day 6
Systemic exposure to CNTX-6016 measured by AUC0-t
CNTX-6016 Pharmacokinetics - tmax
Time Frame: Up to Day 6
Systemic exposure to CNTX-6016 measured by tmax