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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03787004
• Other study ID #: CNTX-6970-HV-102
• Status: Completed
• Phase: Phase 1
• Start date: August 14, 2017
• Est. completion date: September 26, 2018

Study information

• Verified date: December 2018
• Source: Centrexion Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 26, 2018
• Est. primary completion date: August 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Nociceptive Pain

Intervention

Drug:
• CNTX-6970
Oral dose CNTX-6970

Other:
• Placebo
Oral dose placebo

Locations

Country	Name	City	State
United States	Medpace Clinical Pharmacology Unit	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Centrexion Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	CNTX-6970 Pharmacokinetics - AUC0-t	Systemic exposure to CNTX-6970 measured by AUC0-t	Up to Day 13
Primary	CNTX-6970 Pharmacokinetics - AUC0-inf	Systemic exposure to CNTX-6970 measured by AUC0-inf	Up to Day 13
Primary	CNTX-6970 Pharmacokinetics - Cmax	Systemic exposure to CNTX-6970 measured by Cmax	Up to Day 13
Primary	CNTX-6970 Pharmacokinetics - tmax	Systemic exposure to CNTX-6970 measured by tmax	Up to Day 13
Primary	CNTX-6970 Pharmacokinetics - t1/2	Systemic exposure to CNTX-6970 measured by t1/2	Up to Day 13
Secondary	Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)	Number of participants with TEAEs, which includes laboratory test variables	Up to Day 13
Secondary	CNTX-6970 Pharmacodynamics - Emax	Pharmacodynamic effect on MCP-1 and RANTES measured by Emax	Up to Day 13
Secondary	CNTX-6970 Pharmacodynamics - PD tmax	Time to maximum pharmacodynamic effect on MCP-1 and RANTES measured by tmax	Up to Day 13