A Placebo-Controlled, Two-Part Study, Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects

NCT03787004 | Completed Phase 1 FDA Drug

• 1 other identifier: CNTX-6970-HV-102
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 1, placebo-controlled, two part study with either single dose or multiple increasing oral dose to evaluate the safety, pharmacokinetics, and pharmacodynamics of CNTX-6970 in healthy subjects.

Conditions

Chronic Pain; Nociceptive Pain

Keywords

Chronic Pain; Nociceptive Pain; Mixed Pain

Outcome Measures

Primary Outcomes (6)

• CNTX-6970 Pharmacokinetics - fasted state or high-fat standardized meal

  Food effects on pharmacokinetics of CTNX-6790 for Part 1 participants

  Up to Day 3

• CNTX-6970 Pharmacokinetics - AUC0-t

  Systemic exposure to CNTX-6970 measured by AUC0-t

  Up to Day 13

• CNTX-6970 Pharmacokinetics - AUC0-inf

  Systemic exposure to CNTX-6970 measured by AUC0-inf

  Up to Day 13

• CNTX-6970 Pharmacokinetics - Cmax

  Systemic exposure to CNTX-6970 measured by Cmax

  Up to Day 13

• CNTX-6970 Pharmacokinetics - tmax

  Systemic exposure to CNTX-6970 measured by tmax

  Up to Day 13

• CNTX-6970 Pharmacokinetics - t1/2

  Systemic exposure to CNTX-6970 measured by t1/2

  Up to Day 13

Secondary Outcomes (3)

• Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)

  Up to Day 13

• CNTX-6970 Pharmacodynamics - Emax

  Up to Day 13

• CNTX-6970 Pharmacodynamics - PD tmax

  Up to Day 13

Study Arms (4)

Part 1 Cohort 1 (Single Dose)

EXPERIMENTAL

Single 100 mg oral dose of CNTX-6970 (film-coated tablet or enteric-coated tablet)

Drug: CNTX-6970

Part 1 Cohort 2 (Single Dose)

EXPERIMENTAL

Single 100 mg oral dose of CNTX-6970 film-coated tablet

Drug: CNTX-6970

Part 2 (Multiple Ascending Dose)

EXPERIMENTAL

100 mg, 300 mg, and 600 mg CNTX-6970 oral tablet

Drug: CNTX-6970

Part 2 Placebo

PLACEBO COMPARATOR

Placebo oral tablet

Other: Placebo

Interventions

CNTX-6970 DRUG

Oral dose CNTX-6970

Part 1 Cohort 1 (Single Dose); Part 1 Cohort 2 (Single Dose); Part 2 (Multiple Ascending Dose)

Placebo OTHER

Oral dose placebo

Part 2 Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is in good general health as determined by the Investigator's review
• Has a body mass index (BMI) between 18 and 35kg/m\^2, inclusive
• For females, is not currently pregnant or breastfeeding 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:

• Has a history of cardiac disease, including congestive heart failure, angina, or any arrhythmia
• Has diabetes mellitus, acromegaly, clinically active thyroid disease, or other active endocrinopathy
• 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)
• Has used within 14 days prior to the first admission or has plans to use during the study any over-the-counter medicinal products, including herbal and dietary supplements (except for occasional use of acetaminophen or NSAIDs, such as ibuprofen or naproxen; calcium; or Vitamin D)
• Use of any of the following:
• Human growth hormone, octreotide, anti-diabetic medication, or thyroid suppressors or supplements
• Immunosuppressive drugs within 30 days of study start, or 5 half-lives of the drug (whichever is longer), or plans to use during the study

Sponsors & Collaborators

• Centrexion Therapeutics: lead

Study Sites (1)

Medpace Clinical Pharmacology Unit

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Conditions

Chronic Pain; Nociceptive Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Randall M. Stevens, MD

  Centrexion Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Part 1: Open Label Part 2: Double-Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: December 26, 2018
• Study Start: August 14, 2017
• Primary Completion: August 19, 2018
• Study Completion: September 26, 2018
• Last Updated: December 26, 2018

Record last verified: 2018-12

Locations

US (1)