A Single and Multiple-Dose Study of MK-8521 in Healthy and Obese Males (MK-8521-002)

Summary

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-8521.

Part 1 primary hypothesis: Administration of single subcutaneous (SC) doses of MK-8521 is sufficiently safe and well- tolerated in healthy participants, based on assessment of clinical and laboratory adverse experiences, to permit continued clinical investigation.

Part 2: Administration of multiple once daily SC doses of MK-8521 is sufficiently safe and well-tolerated in healthy lean and obese participants, based on assessment of clinical and laboratory adverse experiences, to permit continued clinical investigation.

Conditions

• Type 2 Diabetes Mellitus

Interventions

DRUG

MK-8521 35μg

Single dose 35μg subcutaneous (SC) injection in a treatment period (Part 3, Panel H)

DRUG

MK-8521 100μg

Single dose 100μg SC injection in a treatment period (Part 1, Panel A) and (Part 2, Panel D)

DRUG

MK-8521 125μg

Single dose 125μg SC injection in a treatment period (Part 2, Panel E) and (Part 3, Panel H)

DRUG

MK-8521 150μg

Single dose 150μg SC injection in a treatment period (Part 1, Panel B)

DRUG

MK-8521 175μg

Single dose 175μg SC injection in a treatment period (Part 1, Panel B)

DRUG

MK-8521 200μg

Single dose MK-8521 200μg SC injection in a treatment period (Part 1, Panel B)

DRUG

MK-8521 300μg

Single dose 300μg SC injection in a treatment period (Part 1, Panel A)

DRUG

MK-8521 50/72μg

MK-8521 50μg SC injection Days 1-5 and 72μg Days 6-10 (Part 2, Panel C)

DRUG

MK-8521 72/125μg

MK-8521 72μg SC injection Days 1-7 and 125μg Days 8-14 (Part 2, Panel F)

DRUG

MK-8521 100/150μg

MK-8521 100μg SC injection Days 1-5 and 150μg Days 6-10 SC in a treatment period (Part 2, Panel D)

DRUG

MK-8521 125/150μg

MK-8521 SC 125μg SC injection Days 1-5 and 150μg Days 6-10 (Part 2, Panel E)

DRUG

Placebo

Placebo to MK-8521 SC injection in a treatment period (Parts 1, 2, and 3)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  lead INDUSTRY

Principal Investigators

• Study Director · Merck Sharp & Dohme LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-05-10

Primary Completion

2013-09-17

Completion

2013-09-17