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

Lotus Clinical Research

Status and phase: Unknown; Phase 1

Conditions: Surgery; Pain, Acute; Neuropathy; Acute Pain

Treatments: Drug: CT-044 HCl

Study type: Interventional

Funder types: Other

Identifiers

NCT04175743

CT044-002

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 21 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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21 participants in 3 patient groups

200 mg CT-044 HCl or Placebo

Experimental group

Description:

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

Treatment:

Drug: CT-044 HCl

400 mg CT-044 HCl or Placebo

Experimental group

Description:

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

Treatment:

Drug: CT-044 HCl

600 mg CT-044 HCl or Placebo

Experimental group

Description:

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

Treatment:

Drug: CT-044 HCl