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

NCT03385369 | Completed Phase 1 FDA Drug

• 1 other identifier: D5670C00012
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Safety; Healthy Subjects

Keywords

MEDI0382; Safety; Tolerability; Pharmacokinetics; Immunogenicity

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

  An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug and up to Day 29.

  Day 1 through Day 29

• Number of Participants With Treatment Emergent Adverse Events of Special Interest (AESIs)

  An AESI (serious or non-serious) was one of scientific and medical interest specific to understanding of study drug and may have required close monitoring and rapid communication by investigator to the sponsor.

  Day 1 through Day 29

• Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs

  Number of participants with TEAEs related to clinically significant ECG abnormalities are reported.

  Day 1 through Day 29

• Number of Participants With Vital Signs Abnormalities Reported as TEAEs

  Number of participants with TEAEs related to vital sign abnormalities are reported.

  Day 1 through Day 29

• Number of Participants With Abnormal Laboratory parameters Reported as TEAEs

  Number of participants with TEAEs related to clinically significant abnormal laboratory parameter are reported.

  Day 1 through Day 29

Secondary Outcomes (7)

• Number of Participants With Postive Anti-Drug Antibodies (ADA) Titer to MEDI0382

  Baseline (Day-1), Day 8, and Day 29

• Maximum Observed Plasma Concentration (Cmax) of MEDI0382

  Pre dose; and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose

• Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI0382

  Pre dose; and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose

• Area Under the Concentration-time Curve From Time Zero to Last Time of Quantifiable Concentration (AUC0 last) of MEDI0382

  Pre dose; and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose

• Time to Maximum Observed Plasma Concentration (tmax) of MEDI0382

  Pre dose; and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose

Study Arms (6)

Placebo Japanese Descent

PLACEBO COMPARATOR

Participants of Japanese descent will receive a single subcutaneous injection of placebo matching to MEDI0382.

Drug: Placebo

MEDI0382 50 mcg Japanese Descent

EXPERIMENTAL

Participants of Japanese descent will receive a single subcutaneous dose of 50 mcg MEDI0382.

Drug: MEDI0382

MEDI0382 100 mcg Japanese Descent

EXPERIMENTAL

Participants of Japanese descent will receive a single subcutaneous dose of 100 mcg MEDI0382.

Drug: MEDI0382

MEDI0382 150 mcg Japanese Descent

EXPERIMENTAL

Participants of Japanese descent will receive a single subcutaneous dose of 150 mcg MEDI0382.

Drug: MEDI0382

Placebo Chinese Descent

EXPERIMENTAL

Participants of Chinese descent will receive a single subcutaneous injection of placebo matching to MEDI0382.

Drug: Placebo

MEDI0382 100 mcg Chinese Descent

EXPERIMENTAL

Participants of Chinese descent will receive a single subcutaneous dose of 100 mcg MEDI0382.

Drug: MEDI0382

Interventions

MEDI0382 DRUG

Single dose of MEDI0382

MEDI0382 100 mcg Chinese Descent; MEDI0382 100 mcg Japanese Descent; MEDI0382 150 mcg Japanese Descent; MEDI0382 50 mcg Japanese Descent

Placebo DRUG

Single dose of placebo

Placebo Chinese Descent; Placebo Japanese Descent

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (1)

Research Site

Anaheim, California, 92801, United States

Location

MeSH Terms

Interventions

cotadutide

Study Officials

• Peter J Winkle, MD, FACP, FACG, CPI

  Anaheim Clinical Trials LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 28, 2017
• Study Start: January 5, 2018
• Primary Completion: April 12, 2018
• Study Completion: April 12, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

US (1)