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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-04

Study Completion Date

2020-09-30

Brief Summary

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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).

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Detailed Description

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Subjects meeting all inclusion and exclusion criteria will be randomized to receive CT-044 HCl or placebo in three successive dose escalating cohorts of 8 subjects each (2 placebo and 6 active drug per dose level). Subjects will receive multiple oral CT-044 HCl doses for 7 days. Subjects will be monitored in-house for vital signs, physical examination, electrocardiogram (ECG), safety laboratory testing and documentation of adverse signs and symptoms. Serial blood and urine samples will be collected to evaluate CT-044 HCl levels in plasma and urine.

Eligible subjects will be admitted to the Clinical Trial Unit on the day prior to dosing (Day -1) and remain in house until Day 9 (discharge day). Subjects will return to the Clinical Trial Unit on an outpatient basis for follow-up (Day 13, ± 1 day).

Conditions

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Acute Pain Pain, Acute Surgery Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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).

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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200 mg CT-044 HCl or Placebo

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

Group Type EXPERIMENTAL

CT-044 HCl

Intervention Type DRUG

CT-044 HCl is a reactive species decomposition accelerant

400 mg CT-044 HCl or Placebo

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

Group Type EXPERIMENTAL

CT-044 HCl

Intervention Type DRUG

CT-044 HCl is a reactive species decomposition accelerant

600 mg CT-044 HCl or Placebo

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

Group Type EXPERIMENTAL

CT-044 HCl

Intervention Type DRUG

CT-044 HCl is a reactive species decomposition accelerant

Interventions

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CT-044 HCl

CT-044 HCl is a reactive species decomposition accelerant

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes