A Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Overweight/Obese Subjects of Japanese or Chinese Descent

Completed · Phase 1 · Has a placebo group

Conditions studied: Safety, Healthy Subjects

In brief

This is a phase I, randomized, blinded study to evaluate the safety and pharmacokinetics of MEDI0382 following single dose administration to overweight/obese subjects of Japanese or Chinese descent

Key facts

Study ID

NCT03385369

Run by

MedImmune LLC

People needed

32

Starts

2018-01-05

Expected to finish

2018-04-12

Last updated by the study team

2019-04-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects must meet all of the following criteria:
• Healthy subjects age 18 to 65 years inclusive at the time of consent.
• Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the USA), obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
• Female subjects of childbearing potential must have a negative serum or urine pregnancy test at screening and randomization, and must not be lactating.
• Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from screening and must agree to continue using such precautions through to the end of the study. It is strongly recommended for the male partner of a female subject to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.
• Subject has a body weight ≥ 50 kg (110 lbs) and a BMI ≥ 23 and ≤ 40 kg/m2 inclusive.
• Venous access suitable for multiple cannulations.
• Part A only:
• Subject is a native of Japan or a Japanese American; defined as having both parents and four grandparents who are Japanese. This includes second and third generation subjects of Japanese descent whose parents or grandparents are living in a country other than Japan.
• Part B only:
• Subject is a native of China or a Chinese American; defined as having both parents and four grandparents who are Chinese. This includes second and third generation subjects of Chinese descent whose parents or grandparents are living in a country other than China.
• ____________________________________________________________

You may not qualify if…

• Any of the following would exclude the subject from participation in the study:
• Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results. Specific examples are:
• Past history of acute or chronic pancreatitis, or pancreatic amylase or lipase greater than twice the upper limit of normal (ULN) at screening.
• Past history of gastroparesis requiring treatment.
• Past history of surgery affecting the upper GI tract likely to affect the interpretation of safety and tolerability data.
• History of cholelithiasis leading to episodes of acute cholecystitis not treated by cholecystectomy, or known biliary disease.
• History of or family history of multiple endocrine neoplasia type 2; or serum calcitonin suggestive of thyroid C-cell hyperplasia (calcitonin level > 50 ng/L); or medullary thyroid carcinoma at screening.
• Past history of clinically significant cardiac rhythm disturbance (eg, permanent or paroxysmal atrial fibrillation/flutter, paroxysmal supraventricular tachycardia, paroxysmal ventricular tachycardia, presence of an implantable pacemaker device or cardioverter/defibrillator).
• History of treated or symptomatic cardiac failure.
• Impaired renal function, defined as estimated glomerular filtration rate < 60 mL/minute/1.73 m2 at screening.
• History of previous myocardial infarction or cerebrovascular accident (eg, stroke).
• History or presence of GI, renal, or hepatic disease (with the exception of Gilbert's syndrome), or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• History of cancer, with the exception of non-melanoma skin cancer.
• Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing.
• Positive hepatitis B surface antigen or hepatitis C virus antibody serology at screening.
• Positive human immunodeficiency virus test at screening or use of antiretroviral medications as determined by medical history or subject's verbal report.
• Any of the following based on screening blood tests:
• Aspartate aminotransferase (AST) ≥ 1.5 × ULN.
• Alanine aminotransferase (ALT) ≥ 1.5 × ULN.
• Total bilirubin ≥ 1.5 × ULN.
• Hemoglobin below 12 g/dL.
• Neutrophils < 1.5 × 10\^9/L.
• Thyroid stimulating hormone level above the normal range.
• Use of any of the following medicinal products:
• Concurrent or previous use of a GLP-1 receptor agonist.

Where it is running

• Research Site — Anaheim, California, United States

Full record on ClinicalTrials.gov

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