A Study to Evaluate the Safety and Pharmacokinetics of CNTX-6016 in Healthy Subjects

Centrexion Therapeutics

Status and phase: Completed; Phase 1

Conditions: Nociceptive Pain; Chronic Pain; Pain

Treatments: Other: Other: Placebo; Drug: CNTX-6016

Study type: Interventional

Funder types: Industry

Identifiers

NCT04154501

CNTX-6016o-HV-101

Details and patient eligibility

About

A Phase 1 double-blind, placebo-controlled, randomized single ascending dose incorporating an open-label, 2-period crossover, food effect cohort.

Enrollment: 68 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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:

• 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 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).
• Positive urine screen for alcohol, cotinine, THC and/or drugs of abuse.
• Ingestion of food or beverages containing grapefruit and/or grapefruit juice and/or pomelos during the 7 days prior to dosing and/or during the study period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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68 participants in 18 patient groups, including a placebo group

Cohort 1 Placebo

Placebo Comparator group

Description:

Oral Placebo Capsule

Treatment:

Other: Other: Placebo

Cohort 1 Drug

Experimental group

Description:

25 mg Oral Capsule

Treatment:

Drug: CNTX-6016

Cohort 2 Placebo

Placebo Comparator group

Description:

Oral Placebo Capsule

Treatment:

Other: Other: Placebo

Cohort 2 Drug

Experimental group

Description:

50 mg Oral Capsule

Treatment:

Drug: CNTX-6016

Cohort 3 Placebo

Placebo Comparator group

Description:

Oral Placebo Capsule

Treatment:

Other: Other: Placebo

Cohort 3 Drug

Experimental group

Description:

100 mg Oral Capsule

Treatment:

Drug: CNTX-6016

Cohort 4 Placebo

Placebo Comparator group

Description:

Oral Placebo Capsule

Treatment:

Other: Other: Placebo

Cohort 4 Drug

Experimental group

Description:

300 mg Oral Capsule

Treatment:

Drug: CNTX-6016

Cohort 5 Placebo

Placebo Comparator group

Description:

Oral Placebo Capsule

Treatment:

Other: Other: Placebo

Cohort 5 Drug

Experimental group

Description:

450 mg Oral Capsule

Treatment:

Drug: CNTX-6016

Cohort 6 Placebo

Placebo Comparator group

Description:

Oral Placebo Capsule

Treatment:

Other: Other: Placebo

Cohort 6 Drug

Experimental group

Description:

600 mg Oral Capsule

Treatment:

Drug: CNTX-6016

Cohort 7 Placebo

Placebo Comparator group

Description:

Oral Placebo Capsule

Treatment:

Other: Other: Placebo

Cohort 7 Drug

Experimental group

Description:

800 mg Oral Capsule

Treatment:

Drug: CNTX-6016

Cohort 9 Placebo

Placebo Comparator group

Description:

Oral Placebo Capsule

Treatment:

Other: Other: Placebo

Cohort 9 Drug

Experimental group

Description:

1000 mg Oral Capsule

Treatment:

Drug: CNTX-6016

Cohort 8 Fasted

Experimental group

Description:

Participant will take 300 mg Oral Capsule in a fasting state, and then fed state.

Treatment:

Drug: CNTX-6016

Cohort 8 Fed

Experimental group

Description:

Participant will take 300 mg Oral Capsule in a fed state, and then fasting state.

Treatment:

Drug: CNTX-6016