- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04277910
A SAD/MAD Study to Evaluate the Safety, Tolerability, PK and PD of MT2004
March 25, 2022 updated by: Xi'an Biocare Pharma Ltd.
A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, SAD/MAD Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MT2004
This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of MT2004 following oral single and multiple ascending dose administration.
Study Overview
Detailed Description
A total of 48 subjects will be evaluated with 36 subjects randomized to receive active drug and 12 subjects randomized to receive placebo in a double-blind fashion (eight subjects per each dose cohort, six subjects randomized to active drug and two subjects randomized to placebo).
A separate open panel of 8 subjects will receive a single dose of MT2004 under fed conditions following the last of the SAD dose escalation cohorts.
The dose level will be selected by the sponsor based upon the safety and PK data generated in each dose escalation cohort of the SAD part of the trial.
A total of 24 subjects will receive MT2004 (8 subjects in each dose cohort for a total of 3 cohorts, 6 subjects randomized to active drug and 2 subjects randomized to placebo per cohort).
MT2004 dosing regimens (dose levels and duration of administration) will be determined based on the collective SAD PK and safety data from Part 1 and nonclinical data of MT2004 (pharmacology and toxicology).
Tentative dosing regimen is once daily for a consecutive 14 days.
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Pharmaron CPC, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Are capable of giving informed consent and complying with study procedures;
- Are between the ages of 18 and 55 years, inclusive;
Female subjects have a negative urine pregnancy test result at screening and Day -1, and meet one of the following criteria:
- Using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives) [e.g., hormonal contraceptives (oral, patch, injectable or vaginal ring), implantable device (implantable rod or intrauterine device), or a double barrier (e.g., diaphragm, cervical cap, oral, patch or vaginal hormonal contraceptive, condom, spermicide, or sponge)]
- Surgically sterile for at least 3 months prior to screening by one of the following means:
- Bilateral tubal ligation
- Bilateral salpingectomy (with or without oophorectomy)
- Surgical hysterectomy
- Bilateral oophorectomy (with or without hysterectomy)
- Postmenopausal, defined as the following:
- Last menstrual period greater than 12 months prior to screening
- Postmenopausal status confirmed by serum follicle stimulating hormone (FSH) and estradiol levels at screening;
- Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, clinical laboratory tests, 12- lead ECG, and vital signs;
- Normal renal function as determined by Investigator following review of clinical laboratory test results;
- Non-smoker and no more than 2 tobacco-containing products including nicotine replacement products in last 6 months;
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive and body weight not less than 50 kg;
- Willing and able to adhere to study restrictions and to be confined at the clinical research center.
- Male subjects with female partners of child bearing potential must agree to use condoms for the duration of the study and until 12 weeks after dosing with the study drug and must refrain from donating sperm for this same period.
Exclusion Criteria:
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;
- Known or suspected malignancy;
- History of pancreatitis or gall stones;
- History of unexplained syncope, symptomatic hypotension or hypoglycemia;
- Family history of long QTc syndrome;
- History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance;
- History of organ transplantation with the exception of cornea transplantation;
- Poor venous access;
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
- Donated or lost >500ml of blood in the previous 3 months;
- Taken an investigational drug or participated in a clinical trial within 3 months (or 5 half- lives), whichever is longer;
- Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the first dose of study drug;
- Hospital admission or major surgery within 6 months prior to screening;
- A history of prescription drug abuse, or illicit drug use within 9 months prior to screening;
- A history of alcohol abuse according to medical history within 9 months prior to screening;
A positive screen for alcohol and/or drugs of abuse at screening or Day
-1;
- An unwillingness or inability to comply with food and beverage restrictions during study participation;
- Use of over-the-counter (OTC) medication within 7 days, and herbal (including St John's Wort, herbal teas, garlic extracts) within 7 days prior to dosing (Note: Use of acetaminophen at < 2 g/day is permitted until 24 hours prior to dosing);
- Pregnant or breast feeding at screening or planning to become pregnant during the study;
- Inability to swallow multiple capsules simultaneously
- Any condition or finding that in the Investigators opinion would put the subject or study conduct at risk if the subject were to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: MT2004
MT2004 oral capsules treated group
|
MT2004 oral capsules
|
Placebo Comparator: Placebo
Placebo oral capsules treated group
|
Placebo oral capsules
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax of MT2004
Time Frame: 48 hours
|
Maximum observed concentration (Cmax) of MT2004
|
48 hours
|
AUClast of MT2004
Time Frame: 48 hours
|
Area under the concentration-time curve (AUC) from Hour 0 to the last measurable concentration (AUC0-last) of MT2004
|
48 hours
|
Tmax of MT2004
Time Frame: 48 hours
|
Time to maximum concentration (Tmax)
|
48 hours
|
T half of MT2004
Time Frame: 48 hours
|
T half of MT2004
|
48 hours
|
Plasma FGF19 Level
Time Frame: 24 hours
|
Plasma FGF19 Level
|
24 hours
|
Serum 7-alpha-hydroxy-4-cholesten-3-one (C4) Level
Time Frame: 24 hours
|
Serum 7-alpha-hydroxy-4-cholesten-3-one (C4) Level
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohamed Al-Ibrahim, MD, Pharmaron CPC, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 9, 2020
Primary Completion (Actual)
April 30, 2021
Study Completion (Actual)
September 30, 2021
Study Registration Dates
First Submitted
February 18, 2020
First Submitted That Met QC Criteria
February 18, 2020
First Posted (Actual)
February 20, 2020
Study Record Updates
Last Update Posted (Actual)
April 5, 2022
Last Update Submitted That Met QC Criteria
March 25, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- MT2004-I-A01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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