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

Primary Purpose

Acute Pain, Pain, Acute, Surgery

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CT-044 HCl

About this trial

This is an interventional other trial for Acute Pain focused on measuring Safety, Tolerability, Escalation, Pharmacokinetics, PK, CT-044 HCl, Ascending, Plasma, Surgical Pain, Acute Pain, Non-Opioid, Neuropathy, Chronic Neuropathy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Lotus Clinical Resarch,LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

200 mg CT-044 HCl or Placebo

400 mg CT-044 HCl or Placebo

600 mg CT-044 HCl or Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04175743

First Posted

November 6, 2019

Last Updated

July 21, 2020

Sponsor

Lotus Clinical Research, LLC

Collaborators

CerSci Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT04175743

Brief Title

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

Official Title

Double-blinded, Placebo-controlled, Sequential Cohort, Multiple-Dose Escalation Study to Evaluate the Safety and Multiple Dose Pharmacokinetics of CT-044 HCl, a Reactive Species Decomposition Accelerant, in Healthy Human Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 4, 2019 (Actual)

Primary Completion Date

August 2020 (Anticipated)

Study Completion Date

September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lotus Clinical Research, LLC

Collaborators

CerSci Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

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).

Masking

ParticipantInvestigator

Masking Description

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.

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

200 mg CT-044 HCl or Placebo

Arm Type

Experimental

Arm Description

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

Arm Title

400 mg CT-044 HCl or Placebo

Arm Type

Experimental

Arm Description

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

Arm Title

600 mg CT-044 HCl or Placebo

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

CT-044 HCl

Intervention Description

CT-044 HCl is a reactive species decomposition accelerant

Primary Outcome Measure Information:

Title

Maximum exposure level of CT-044

Description

Time Frame

49 days

Title

Plasma Pharmacokinetic Concentration of CT-044

Description

Time Frame

32 Hours

Title

Urine Pharmacokinetic Concentration of CT-044

Description

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.

Time Frame

24 Hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Lotus Clinical Resarch,LLC

City

Pasadena

State/Province

California

ZIP/Postal Code

91105

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

34145168

Citation

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.

Results Reference

derived

Learn more about this trial

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

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