Double-blind, Placebo-control, Study to Evaluate the Safety and Pharmacokinetics of CT-044 HCl, in Healthy Volunteers

NCT04175743 | Unknown Phase 1 FDA Drug

• 1 other identifier: CT044-002
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to assess safety, tolerability, and PK of CT-044 HCl in normal healthy volunteers, in a traditional sequential multiple ascending dose paradigm. The multiple-dose escalation is designed to mimic the manner in which the product (CT-044 HCl) would be used to manage ongoing pain in patients (i.e., multiple dosing).

Conditions

Acute Pain; Pain, Acute; Surgery; Neuropathy

Keywords

Safety; Tolerability; Escalation; Pharmacokinetics; PK; CT-044 HCl; Ascending; Plasma; Surgical Pain; Acute Pain; Non-Opioid; Neuropathy; Chronic Neuropathy

Outcome Measures

Primary Outcomes (3)

• Maximum exposure level of CT-044

  Occurrence of maximum exposure level of Cmax of 80 μg/mL and/or AUC0-24 of 450 hr.μg/mL (corresponding to average values obtained at the NOAEL doses in males rat and dog) has been reached in ≥2 subjects in a cohort or if it is expected to be reached in the planned next cohort.

  49 days

• Plasma Pharmacokinetic Concentration of CT-044

  The PK data will be summarized by dose/cohort using appropriate statistics. Actual elapsed time from dosing will be used for the final plasma PK parameter calculations after database lock. Plasma PK samples collected every 8 hours for 32 hours.

  32 Hours

• Urine Pharmacokinetic Concentration of CT-044

  The urine PK concentration of CT-044 will use individual data points to determine the concentration of CT-044 in subjects urine. Urine PK samples collected every 8 hours for 24 hours.

  24 Hours

Study Arms (3)

200 mg CT-044 HCl or Placebo

EXPERIMENTAL

200 mg of CT-044 HCl administered every 8 hours vs placebo

Drug: CT-044 HCl

400 mg CT-044 HCl or Placebo

EXPERIMENTAL

400 mg of CT-044 HCl administered every 8 hours vs placebo

Drug: CT-044 HCl

600 mg CT-044 HCl or Placebo

EXPERIMENTAL

600 mg of CT-044 HCl administered every 8 hours vs placebo

Drug: CT-044 HCl

Interventions

CT-044 HCl DRUG

CT-044 HCl is a reactive species decomposition accelerant

200 mg CT-044 HCl or Placebo; 400 mg CT-044 HCl or Placebo; 600 mg CT-044 HCl or Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index within the range 18.5 to 32.0 kg/m2 (inclusive).
• Healthy subjects as determined by medical history, physical examination including neurological examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests.
• Negative tests for hepatitis B surface antigen, hepatitis C virus antibodies and human immunodeficiency virus (HIV-1 or HIV-2) antibody, and syphilis.
• Nonsmokers (use of any nicotine containing product) or ex-smokers (have ceased smoking for at least 3 months and do not use any drug for smoking cessation.
• Negative screen for alcohol and drugs of abuse.
• Women must not be of childbearing potential by reason of surgery or at least 1 year post-menopausal (i.e., 12 months without menstrual period), or menopause.
• Men must be infertile (at least 3-months post-vasectomy), or truly abstinent of heterosexual intercourse, or heterosexual partner is not of childbearing potential or must agree to use an effective method of contraception. Men must agree to not provide sperm donation during that same period.
• Able and willing to be available for the duration of the study.
• Willing and able to give written informed consent to participate.
• Able to understand and comply with protocol instructions.

Sponsors & Collaborators

• Lotus Clinical Research, LLC: lead
• CerSci Therapeutics: collaborator

Study Sites (1)

Lotus Clinical Resarch,LLC

Pasadena, California, 91105, United States

Location

Related Publications (1)

• Squillace S, Salvemini D. Nitroxidative stress in pain and opioid-induced adverse effects: therapeutic opportunities. Pain. 2022 Feb 1;163(2):205-213. doi: 10.1097/j.pain.0000000000002347. No abstract available.

  PMID: 34145168 DERIVED

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subjects will be assigned a randomization number prior to dosing on Day 1 in the order in which they are enrolled into the study to receive their allocated treatment according to a computer-generated randomization schedule prepared by the unblinded study statistician prior to the start of the study.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is planned to have 3 dose levels (3 study cohorts); the actual dose level cohorts will be decided by the SRC after review of the data from each cohort that was successfully completed in the SAD study. Each dose cohort will include 8 subjects randomized to placebo (2 subjects) or active drug (6 subjects).

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 25, 2019
• Study Start: December 4, 2019
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

US (1)