Celerion
Tempe, Arizona, 85283, United States
NCT Number: NCT03586843
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).
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Tempe, Arizona, 85283, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Part A and Part B:
Part A:
Part B:
Exclusion criteria
Part A and Part B:
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.
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)
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 EOS: 7-14 days after Day 42 of Treatment Period 3 (approximately up to 26 weeks)
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)
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: Approximately up to 6 weeks
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: 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)
Number of participants with antibodies to JNJ-64565111 will be reported.
Time frame: Part A: approximately up to 26 weeks, Part B: approximately up to 11 weeks
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
The number of gastrointestinal adverse events over time will be evaluated upon multiple dosing of JNJ-64565111.
Time frame: From Day 36 until Day 43
Cmax (maximum observed serum analyte concentration) after last dose of JNJ-64565111.
Time frame: From Day 36 until Day 43
AUCtau (measure of the serum drug exposure over the dosing interval) after the last dose of JNJ-64565111.
Janssen Research & Development, LLC
Industry
A Single-dose, Open-label, Randomized, 3-period, 6-sequence, Crossover Study to Evaluate the Relative Bioavailability of JNJ-64565111 After Single Subcutaneous Administration at Different Injection Sites in Otherwise Healthy Overweight/Obese Adult Subjects and A Multiple Dose, Open-label, Titration Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ 64565111 in Otherwise Healthy Obese Adult Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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