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

Study identifier:D5670C00003

ClinicalTrials.gov identifier:NCT03341013

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1, Randomized, Cross-over, Two-period Pilot Study Investigating Bioequivalence Between a Single Dose of Formulation 2 and Formulation 3 of MEDI0382 in Healthy Adult Subjects

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 1

Healthy volunteers

Yes

Study drug

MEDI0382 Formulation 2, MEDI0382 Formulation 3

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 30 Nov 2017

Primary Completion Date: 29 Jan 2018

Study Completion Date: 29 Jan 2018

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other

Verification:

Verified 01 Feb 2019 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

1. Healthy participants age 18 through 45 years at the time of screening.
2. Provision of signed and dated written informed consent prior to study-specific procedures.
3. Body mass index between 19 and 30 kg/m^2 (inclusive) at screening.
4. Good general health as judged by the investigator, based on medical history, physical examination including 12-lead electrocardiogram (ECG), vital signs, and blood and urinary laboratory assessments.
5. Female participants of childbearing potential must have a negative pregnancy test at screening and randomization and must not be lactating.
6. 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 participant 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.

Exclusion Criteria

1. History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, put the participant at risk, influence the participant's ability to participate, or affect the interpretation of the results of the study.
2. Impaired renal function, defined as s-creatinine >= 130 µmol/L.
3. Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2.
4. 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.
5. Any clinically significant abnormal ECG, as judged by the investigator.
6. Active hepatitis B, measured by positive tests of surface antigen HBsAg and/or active hepatitis C, measured by positive hepatitis C virus antibody tests.
7. Positive human immunodeficiency virus antibodies
8. Known or suspected allergy to MEDI0382, any component of the formulation, or related products.
9. Use of any prescription or nonprescription medication, except for paracetamol, hormonal contraceptives, and vitamins within the last 72 hours prior to check-in.
10. History of alcoholism or drug abuse during the last 12 months.
11. Smoking of cigarettes or other tobacco products.
12. 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.
13. Blood donation within the last 3 months.
14. Participation in any other trial investigating other products or involving blood sampling within the past 30 days.
15. Potentially noncompliant or uncooperative, as judged by the investigator.
16. Substance dependence likely to impact participant safety or compliance with study procedures.
17. Psychiatric illness such that participants have been committed to an institution by way of official or judicial order.
18. Involvement of any AstraZeneca, MedImmune, the contract research organization, or the study site employee or their close relatives.

No locations available

Arms	Assigned Interventions
Experimental: MEDI0382 Formulation 2 Then MEDI0382 Formulation 3 Participants received a single SC dose of MEDI0382 Formulation 2 (100 μg) on Day 1 (treatment period 1), followed by a single SC dose of MEDI0382 Formulation 3 (100 μg) on Day 10 (treatment period 2) of the study. Treatment periods 1 and 2 were separated by a washout period of minimum 7 days.	Drug: MEDI0382 Formulation 2 Participants received a single SC dose of MEDI0382 Formulation 2 (100 μg) on either Day 1 of treatment period 1 or Day 10 of treatment period 2. Drug: MEDI0382 Formulation 3 Participants received a single SC dose of MEDI0382 Formulation 3 (100 μg) on either Day 1 of treatment period 1 or Day 10 of treatment period 2.
Experimental: MEDI0382 Formulation 3 Then MEDI0382 Formulation 2 Participants received a single SC dose of MEDI0382 Formulation 3 (100 μg) on Day 1 (treatment period 1), followed by a single SC dose of MEDI0382 Formulation 2 (100 μg) on Day 10 (treatment period 2) of the study. Treatment periods 1 and 2 were separated by a washout period of minimum 7 days.	Drug: MEDI0382 Formulation 2 Participants received a single SC dose of MEDI0382 Formulation 2 (100 μg) on either Day 1 of treatment period 1 or Day 10 of treatment period 2. Drug: MEDI0382 Formulation 3 Participants received a single SC dose of MEDI0382 Formulation 3 (100 μg) on either Day 1 of treatment period 1 or Day 10 of treatment period 2.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]