Open-label, Crossover, Food Effect Study to Evaluate CT-044 in Healthy Human Volunteers

NCT04252833 | Completed Phase 1 FDA Drug

• 1 other identifier: CT044-003
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This open-label study will be conducted to assess the bioavailability and PK of oral single doses of CT-044 following administration with and without food and to evaluate the safety and tolerability of CT-044 when given with and without food.

Conditions

Pain, Acute; Acute Pain; Surgery; Neuropathy

Keywords

Safety; Tolerability; Single Dose; Pharmacokinetics; PK; CT-044 HCl; Food Effect

Outcome Measures

Primary Outcomes (11)

• Comparison of the maximum drug concentration

  Following administration with and without food (Cmax) of oral single dose of CT-044

  7 days

• Comparison of the Time of maximum drug concentration (tmax)

  Following a single oral dose of CT-044 following administration with and without food

  7 days

• Comparison of the Area under the drug concentration Time curve from time 0 extrapolated to infinity (AUC0-∞)

  Following a single oral dose of CT-044 following administration with and without food

  7 days

• Comparison of the Area under the drug concentration Time curve from time 0 to the time of the last quantifiable concentration (AUC0-last)

  Following a single oral dose of CT-044 following administration with and without food

  7 days

• Comparison of the Apparent oral clearance (CL/F)

  Following a single oral dose of CT-044 following administration with and without food

  7 days

• Comparison of the Apparent volume distribution (Vz/F)

  Following a single oral dose of CT-044 following administration with and without food

  7 days

• Comparison of the Terminal half-life (t1/2)

  Following a single oral dose of CT-044 following administration with and without food

  7 days

• Comparison of the Terminal rate constant (λz)

  Following a single oral dose of CT-044 following administration with and without food

  7 days

• Comparison of the Relative bioavailability

  Following a single oral dose of CT-044 after administration of a high-fat meal (F)

  7 days

• Peak Plasma Concentration (Cmax)

  Linear mixed model appropriate for a 2-period cross-over design with fixed terms for sequence, period and food condition will be used to investigate the food interaction on the Peak Plasma Concentration (Cmax)

  7 days

• Plasma concentration versus time curve (AUC)

  Linear mixed model appropriate for a 2-period cross-over design with fixed terms for sequence, period and food condition will be used to investigate the food interaction Area under the plasma concentration versus time curve (AUC)

  7 days

Study Arms (1)

CT-044 600 mg

EXPERIMENTAL

The dose to be utilized for the evaluation of food effect will be CT-044 600 mg single dose.

Drug: CT-044

Interventions

CT-044 DRUG

CT-044 HCl is a reactive species decomposition accelerant

CT-044 600 mg

Eligibility Criteria

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

You may qualify if:

• Men and women aged 18 through 55 years, inclusive.
• 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 at screening.
• Nonsmokers or ex-smokers and agrees not to use nicotine containing products from screening through 48 hours after final discharge from the Clinical Trial Unit.
• Negative screen for alcohol and drugs of abuse at screening and admission.
• Women must not be of childbearing potential by reason of surgery or at least 1 year postmenopausal (i.e., 12 months without menstrual period), or menopause confirmed with an estradiol level of \<30 pg/mL and follicle-stimulating hormone level of \>40 IU/L at screening.
• Men must be infertile, or truly abstinent of heterosexual intercourse, or heterosexual partner is not of childbearing potential, or must agree to use an effective method of contraception throughout the study and for 28 days after last dose of study drug. 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.
• Agree not to receive any vaccination within 21 days prior to admission and through Day 7 after final discharge from the Clinical Trial Unit.
• Agrees not to use nonprescription drugs, including vitamins, antacids, and herbal and dietary supplements within 14 days or 5 drug elimination half-lives, whichever is longer.

You may not qualify if:

• \- Subjects with significant previous or ongoing disease or disorder, including for example: cardiovascular diseases; hypertension; cancer or neoplasia; diabetes; hepatic, endocrine, metabolic, respiratory, renal, gastrointestinal (except appendectomy), hematological or Axis I or II psychiatric disorders.
• Clinical laboratory test results outside the normal range at screening that are considered clinically significant by the Investigator.
• Clinically significant, in the opinion of the Investigator, infection or inflammation at time of screening or admission.
• Acute gastrointestinal symptoms at time of screening or admission or a clinical diagnosis of irritable bowel syndrome (IBS) per ROME IV criteria.
• Average QTcF interval recorded on screening and pre-dose ECG must be not more than 450 msec.
• Any current or previous illicit use of Class A drugs such as opiates, cocaine, ecstasy, lysergic acid diethylamide (LSD), and amphetamines (Class B).
• An alcoholic intake greater than 14 units per week or unwillingness to stop alcohol consumption for the duration of the study.
• Use of any investigational medication within 3 months prior to the start of this study or scheduled to receive an investigational drug during the course of this study, or for 30 days or five half-lives, whichever is longer, following the last dose of study medication.
• History of severe allergies or multiple adverse drug reactions, including penicillin and cephalosporins.
• Any condition which compromises their ability to give informed consent or to communicate with the Investigator as required for the completion of this study.

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The dose to be utilized for the evaluation of food effect will be CT-044 600 mg single dose.

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: February 5, 2020
• Study Start: February 18, 2020
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: June 12, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)