A Phase 1b Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of JNJ-64565111 in Participants With Type 2 Diabetes Mellitus



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 70
Updated:4/17/2018
Start Date:August 1, 2017
End Date:February 19, 2018

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A Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-64565111 in Men and Women With Type 2 Diabetes Mellitus

The purpose of this Phase 1b study is to assess the safety and tolerability of JNJ-64565111
in adult men and women (of non-child bearing potential) with Type 2 Diabetes Mellitus.


Inclusion Criteria:

- Diagnosis of type 2 diabetes mellitus (T2DM) at least 3 months prior to Screening

- Hemoglobin A1c (HbA1c) greater than or equal to (>=) 7.0 percent (%) and lesser than
or equal to (<=)9.5% at Screening

- On a stable treatment regimen for at least 3 months prior to Screening of (1) diet and
exercise, and/or (2) metformin monotherapy (at a dose of at least 1,000 milligram (mg)
per day)

- Body mass index (BMI) ranging from 25 to 40 kilogram per square meter (kg/m^2)
(inclusive), weighing between 75 and 130 kg (inclusive)

- A woman must have a negative highly sensitive serum beta-human chorionic gonadotropin
(beta- hCG) at Screening and Day -2

- Blood pressure (measured after the participant is sitting/ resting quietly for 5
minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and
between 60 and 100 mmHg diastolic, inclusive at Screening (sitting) and Day -2
(supine). If the average of the first triplicate blood pressure assessment is out of
range, up to 2 repeated triplicate assessments are permitted

Exclusion Criteria:

- History or current diagnosis of acute or chronic pancreatitis

- Familial or personal history of multiple endocrine neoplasia type
2,familial/non-familial medullary thyroid carcinoma

- Donated blood or blood products or lost a significant amount of blood (>500 milliliter
[mL]) within 3 months before the first administration of study drug

- History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV)
positive, or other clinically active liver disease, or tests positive for HBsAg or
anti-HCV at Screening

- History of human immunodeficiency virus (HIV) antibody positive, or tests positive for
HIV at Screening
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Miami, Florida 33175
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855 3rd Avenue
Chula Vista, California 91911
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Chula Vista, CA
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