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

Centrexion Therapeutics

Status and phase: Completed; Phase 1

Conditions: Nociceptive Pain; Chronic Pain

Treatments: Other: Placebo; Drug: CNTX-6970

Study type: Interventional

Funder types: Industry

Identifiers

NCT03787004

CNTX-6970-HV-102

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 4 patient groups, including a placebo group

Part 1 Cohort 1 (Single Dose)

Experimental group

Description:

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

Treatment:

Drug: CNTX-6970

Part 1 Cohort 2 (Single Dose)

Experimental group

Description:

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

Treatment:

Drug: CNTX-6970

Part 2 (Multiple Ascending Dose)

Experimental group

Description:

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

Treatment:

Drug: CNTX-6970

Part 2 Placebo

Placebo Comparator group

Description:

Placebo oral tablet

Treatment:

Other: Placebo