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

Painful Diabetic Neuropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04857957
• Other study ID #: CNTX-6016o-HV/PDN-102
• Status: Completed
• Phase: Phase 1
• Start date: April 14, 2021
• Est. completion date: August 30, 2023

Study information

• Verified date: October 2023
• Source: Centrexion Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Pain
• Painful Diabetic Neuropathy

Intervention

Drug:
• Oral dose CNTX-6016 or oral dose Placebo
CNTX-6016 or Placebo

Locations

Country	Name	City	State
United States	AltaSciences	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Centrexion Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CNTX-6016 Effect of Age and Sex in all Cohorts	Systemic exposure to CNTX-6016 By Cmax pooled from all cohorts over full dose range.	Up to Day 14
Other	CNTX-6016 Effect of Age and Sex in all Cohorts	Systemic exposure to CNTX-6016 By AUC pooled from all cohorts over full dose range.	Up to Day 14
Other	CNTX-6016 Efficacy - PDN Cohort	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"	Up to Day 14
Other	CNTX-6016 Efficacy - PDN Cohort	Efficacy measured by PainDETECT Questionnaire	Up to Day 14
Other	CNTX-6016 Efficacy - PDN Cohort	Efficacy measured by Patient Global Impression of Change	Up to Day 14
Primary	Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability) with CNTX-6016	Number of participants with TEAEs, which includes laboratory test variables	Up to 45 days
Primary	CNTX-6016 Pharmacokinetics - Cmax	Systemic exposure to CNTX-6016 measured by Cmax	Up to Day 6
Primary	CNTX-6016 Pharmacokinetics - AUC0-t	Systemic exposure to CNTX-6016 measured by AUC0-t	Up to Day 6
Primary	CNTX-6016 Pharmacokinetics - t1/2	Systemic exposure to CNTX-6016 measured by t1/2	Up to Day 6
Primary	CNTX-6016 Pharmacokinetics - tmax	Systemic exposure to CNTX-6016 measured by tmax	Up to Day 6