The purpose of this study is to compare the relative bioavailability of JNJ-64565111 between subcutaneous (SC) administrations in the upper arm versus the abdomen, and between SC administrations in the thigh versus the abdomen in otherwise healthy overweight/obese participants (Part A) and to assess the gastrointestinal tolerability of JNJ-64565111 following a dose titration in otherwise healthy obese participants at 6 weeks (Part B).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
52
JNJ-64565111 SC will be administered on Day 1 of Treatment Periods 1, 2 and 3 as per the assigned treatment sequence in Part A and as ascending doses on Days 1, 8, 15, 22, 29 and 36 in Part B.
Celerion
Tempe, Arizona, United States
Part A: Maximum Observed Serum Concentration of JNJ-64565111 (Cmax)
Cmax is the maximum observed serum analyte concentration.
Time frame: Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 192, 384, 672 and 984 hours postdose; at End of study (EOS): 7-14 days after Day 42 of Treatment Period 3 (approximately up to 26 weeks)
Part A: Area Under the Serum Concentration Time Curve From Time 0 to Infinite Time (AUC [0-infinity])
AUC \[0-infinity) is the area under the serum concentration versus time curve from time 0 to infinite time, calculated as AUClast + Clast/lambda(z) where Clast is the last observed measurable (non- below quantification limit \[BQL\]) concentration.
Time frame: Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 192, 384, 672 and 984 hours postdose; at EOS: 7-14 days after Day 42 of Treatment Period 3 (approximately up to 26 weeks)
Part A: Area Under the Serum Concentration Time Curve From Time 0 to Time of the Last Measurable Concentration (AUC [0-last])
AUC (0-last) is the area under the serum concentration versus time curve from time 0 to time of the last measurable (non-below quantification limit \[BQL\]) concentration, calculated by linear linear trapezoidal summation.
Time frame: Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 192, 384, 672 and 984 hours postdose; at EOS: 7-14 days after Day 42 of Treatment Period 3 (approximately up to 26 weeks)
Part B: Number of Participants with Gastrointestinal Adverse Events as a Measure of Safety and Tolerability of JNJ-64565111
Number of participants with gastrointestinal adverse events will be assessed. An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily have a causal relationship with the relevant investigational product.
Time frame: Approximately up to 6 weeks
Part A and Part B: Number of Participants with Antibodies to JNJ-64565111
Number of participants with antibodies to JNJ-64565111 will be reported.
Time frame: Part A: Predose, 144, 672 and 984 hours postdose; at EOS: 7-14 days after Day 42 of Treatment Period 3 (approximately up to 26 weeks); Part B: predose (Day 1), postdose on Day 39 or End of Study/Early Withdrawal (approximately up to 7 weeks)
Part A and Part B: Number of Participants with Adverse Events
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily have a causal relationship with the relevant investigational product.
Time frame: Part A: approximately up to 26 weeks, Part B: approximately up to 11 weeks
Part B: Number of Gastrointestinal Adverse Events Over Time Upon Multiple Dosing
The number of gastrointestinal adverse events over time will be evaluated upon multiple dosing of JNJ-64565111.
Time frame: Approximately up to 6 weeks
Part B: Maximum Observed Serum Concentration of JNJ-64565111 (Cmax)
Cmax (maximum observed serum analyte concentration) after last dose of JNJ-64565111.
Time frame: From Day 36 until Day 43
Part B: Area Under the Serum Concentration Versus Time Curve Over the Dosing Interval (AUCtau)
AUCtau (measure of the serum drug exposure over the dosing interval) after the last dose of JNJ-64565111.
Time frame: From Day 36 until Day 43
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