Safety, Tolerability & Pharmacokinetics Study of CNTX-6016 in Healthy Subjects and Subjects With PDN

• Sponsor: Centrexion Therapeutics (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04857957
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 10.5
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief Summary

A Phase 1b/2a 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.

Condition or Disease	Intervention/Treatment	Phase
Painful Diabetic Neuropathy	Drug: Oral dose CNTX-6016 or oral dose Placebo	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Apr 14, 2021
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 300 mg oral dose TID	Drug: Oral dose CNTX-6016 or oral dose Placebo; CNTX-6016 or Placebo
Experimental: Cohort 2 600 mg oral dose TID	Drug: Oral dose CNTX-6016 or oral dose Placebo; CNTX-6016 or Placebo
Experimental: Cohort 3 800 mg oral dose TID	Drug: Oral dose CNTX-6016 or oral dose Placebo; CNTX-6016 or Placebo
Experimental: PDN cohort Dose based on safety in healthy Cohorts 1-3	Drug: Oral dose CNTX-6016 or oral dose Placebo; CNTX-6016 or Placebo

Outcome Measures

Primary Outcome Measures

1. Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability) with CNTX-6016 [Up to 45 days]

   Number of participants with TEAEs, which includes laboratory test variables

2. CNTX-6016 Pharmacokinetics - Cmax [Up to Day 6]

   Systemic exposure to CNTX-6016 measured by Cmax

3. CNTX-6016 Pharmacokinetics - AUC0-t [Up to Day 6]

   Systemic exposure to CNTX-6016 measured by AUC0-t

4. CNTX-6016 Pharmacokinetics - t1/2 [Up to Day 6]

   Systemic exposure to CNTX-6016 measured by t1/2

5. CNTX-6016 Pharmacokinetics - tmax [Up to Day 6]

   Systemic exposure to CNTX-6016 measured by tmax

Other Outcome Measures

1. CNTX-6016 Effect of Age and Sex in all Cohorts [Up to Day 14]

   Systemic exposure to CNTX-6016 By Cmax pooled from all cohorts over full dose range.

2. CNTX-6016 Effect of Age and Sex in all Cohorts [Up to Day 14]

   Systemic exposure to CNTX-6016 By AUC pooled from all cohorts over full dose range.

3. CNTX-6016 Efficacy - PDN Cohort [Up to Day 14]

   Efficacy measured by Numeric Rating Scale. The Numeric Rating Scale is an 11-point pain scale with a range of 0 to 10 where 0 = "no pain" and 10 = "worst possible pain"

4. CNTX-6016 Efficacy - PDN Cohort [Up to Day 14]

   Efficacy measured by PainDETECT Questionnaire

5. CNTX-6016 Efficacy - PDN Cohort [Up to Day 14]

   Efficacy measured by Patient Global Impression of Change

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 59 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

• For males, must agree to use barrier contraception and not to donate sperm

Key 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

• The pain is characterized as burning, painful, cold or electrical shocks in nature

• The pain is associated with tingling, numbness, itching or pins and needles type sensations

• The pain has been present and consistent for ≥ 6 months

Key Exclusion Criteria- PDN Cohort

• Diagnosis of Type 1 diabetes

• Has serious or unstable cardiovascular, hepatic, renal, respiratory or hematological illness

• Has a history or currently active type of cancer except excised or cured basal cell carcinoma.

• Has a History of psychological conditions or neurological disorders

• Has a History of lower back pain with radiculopathy

• Has received non-pharmacological treatment for pain within 14 days

• Has a history of frequent and/or severe allergic reactions with multiple medications

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AltaSciences	Overland Park	Kansas	United States	66212

Sponsors and Collaborators

• Centrexion Therapeutics

Investigators

• Study Chair: Paul Tiseo, PhD, Centrexion Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centrexion Therapeutics
• ClinicalTrials.gov Identifier: NCT04857957
• Other Study ID Numbers: CNTX-6016o-HV/PDN-102
• First Posted: Apr 23, 2021
• Last Update Posted: Apr 23, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centrexion Therapeutics: Painful Diabetic Neuropathy
• Additional relevant MeSH terms: Diabetic Neuropathies; Pain

Study Results

No Results Posted as of Apr 23, 2021