A SAD/MAD Study to Evaluate the Safety, Tolerability, PK and PD of MT2004
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Pharmaron CPC, Inc.
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Mohamed Al-Ibrahim, MD, Pharmaron CPC, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- MT2004-I-A01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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