A Pilot Study Investigating Bioequivalence Between a Single Dose of Formulation 2 and Formulation 3 of MEDI0382

NCT03341013 | Completed Phase 1 FDA Drug

• 1 other identifier: D5670C00003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, open label, cross-over, two-period, pilot study in healthy adult subjects to evaluate the bioequivalence between formulation 2 and formulation 3 of MEDI0382 after a single subcutaneous (SC) dose. The study will be conducted at a single US center. Each subject will be randomized to receive a single 100 μg (or equimolar equivalent) SC dose of both formulation 2 and 3 of MEDI0382 on two different in-house periods separated by a washout period of 7 days. Formulation 3 of MEDI0382 has not been administered to humans previously. Blood samples for PK analyses of MEDI0382 concentrations will be taken predose and at 11 time points up to 48 hours after dosing (Days 3 and 12). Bedside plasma glucose levels will be monitored before meals and at bedtime during Days 1 and 10 and will be measured prior to breakfast on Days 2 and 11.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; GLP-1 receptor agonists

Outcome Measures

Primary Outcomes (2)

• Area under the drug concentration curve

  To evaluate bioequivalence between formulation 2 and formulation 3 of MEDI0382

  48 hours

• Maximum observed plasma concentration of MEDI0382

  To evaluate bioequivalence between formulation 2 and formulation 3 of MEDI0382.

  48 hours

Secondary Outcomes (14)

• Area under the plasma drug concentration versus time curve from zero to infinity and to last observation

  48 hours

• Time to maximum observed plasma drug concentration

  48 hours

• Terminal phase elimination half-life

  48 hours

• Apparent clearance

  48 hours

• Adverse Events

  38 days

Study Arms (2)

Sequence 1

EXPERIMENTAL

formulation 2 on Day 1 and formulation 3 on Day 10

Drug: MEDI0382 Formulation 2; Drug: MEDI0382 Formulation 3

Sequence 2

EXPERIMENTAL

formulation 3 on Day 1 and formulation 2 on Day 10

Drug: MEDI0382 Formulation 2; Drug: MEDI0382 Formulation 3

Interventions

MEDI0382 Formulation 2 DRUG

Sequence 1 Period 1 and Sequence 2 Period 2.

Sequence 1; Sequence 2

MEDI0382 Formulation 3 DRUG

Sequence 1 Period 2 and Sequence 2 Period 1

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects age 18 through 45 years at the time of screening.
• Provision of signed and dated written informed consent prior to study-specific procedures.
• Body mass index between 19 and 30 kg/m2 (inclusive) at screening
• Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG, vital signs, and blood and urinary laboratory assessments.
• Female subjects of childbearing potential must have a negative 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 (see Section 10.2 for definition of females of childbearing potential and for a description of highly effective methods 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 a 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.

You may not qualify if:

• History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, put the subject at risk, influence the subject's ability to participate, or affect the interpretation of the results of the study
• Impaired renal function, defined as s-creatinine ≥ 130 µmol/L
• Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2
• Blood pressure and heart rate in supine position outside the ranges of 90-140 mmHg systolic, 50-90 mmHg diastolic and heart rate 40-100 beats/min following a 10-minute rest period.
• Any clinically significant abnormal ECG, as judged by the investigator
• Active hepatitis B, measured by positive tests of surface antigen HBsAg and/or active hepatitis C, measured by positive hepatitis C virus antibody tests
• Positive human immunodeficiency virus antibodies
• Known or suspected allergy to MEDI0382, any component of the formulation, or related products
• Use of any prescription or nonprescription medication, except for paracetamol, hormonal contraceptives, and vitamins within the last 72 hours prior to check-in
• History of alcoholism or drug abuse during the last 12 months
• Smoking of cigarettes or other tobacco products
• Habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the investigator
• Blood donation within the last 3 months
• Participation in any other trial investigating other products or involving blood sampling within the past 30 days
• Potentially noncompliant or uncooperative, as judged by the investigator

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (1)

Research Site

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: November 14, 2017
• Study Start: November 30, 2017
• Primary Completion: January 29, 2018
• Study Completion: January 29, 2018
• Last Updated: February 14, 2018

Record last verified: 2018-02

Locations

US (1)