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

NCT ID: NCT03787004

Last Updated: 2018-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-14
• Study Completion Date: 2018-09-26

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1 Cohort 1 (Single Dose)

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

Group Type: EXPERIMENTAL

CNTX-6970

Intervention Type: DRUG

Oral dose CNTX-6970

Part 1 Cohort 2 (Single Dose)

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

Group Type: EXPERIMENTAL

CNTX-6970

Intervention Type: DRUG

Oral dose CNTX-6970

Part 2 (Multiple Ascending Dose)

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

Group Type: EXPERIMENTAL

CNTX-6970

Intervention Type: DRUG

Oral dose CNTX-6970

Part 2 Placebo

Placebo oral tablet

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Oral dose placebo

Interventions

CNTX-6970

Oral dose CNTX-6970

Intervention Type: DRUG

Placebo

Oral dose placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centrexion Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Randall M. Stevens, MD

Role: STUDY_CHAIR

Centrexion Therapeutics

Locations

Medpace Clinical Pharmacology Unit

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

CNTX-6970-HV-102

Identifier Type: -

Identifier Source: org_study_id