Obesity
Conditions
Brief summary
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).
Interventions
DRUGJNJ-64565111
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.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Part A and Part B: \- If a woman, must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry, throughout the study and for at least 30 days after the last dose of study drug Part A: * If a woman, must have a negative serum beta human chorionic gonadotropin (hCG) pregnancy test at screening; and a negative serum pregnancy test on Day -1 of each treatment period * Body mass index (weight \[kilogram {kg}\]/height\^2 \[meter {m}\^2\]) between 25-40 kg/m\^2 (inclusive), and body weight not less than 75 kg Part B: * A woman must have a negative serum beta-hCG pregnancy test at screening, on Day 1, and before each SC injection, except on Day 8(+1). On Day 8(+1), women must have a negative serum or urine pregnancy test depending on the test performed at the investigator's discretion * Body mass index (weight \[kg\]/height\^2 \[m\]\^2) between 30-50 kg/m\^2 (inclusive), and body weight not less than 75 kg
Exclusion criteria
Part A and Part B: * History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities (that is \[ie\], fasting triglycerides greater than or equal to (\>=)500 milligram per deciliter (mg/dL) and/or total cholesterol \>=300 mg/dL), significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results * Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) at screening or at admission to the study center as deemed appropriate by the investigator * Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center as deemed appropriate by the investigator. Participants with serum sodium less than (\<)130 milliequivalents per liter (mEq/L) at screening should be excluded * Known allergy to the study drug or any of the excipients of the formulation * Donated blood or blood products or had substantial loss of blood (more than 500 milliliters \[mL\]) within 3 months before the first administration of study drug or intention to donate blood or blood products during the study or within 2 months after the completion of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Maximum Observed Serum Concentration of JNJ-64565111 (Cmax) | 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. |
| Part A: Area Under the Serum Concentration Time Curve From Time 0 to Infinite Time (AUC [0-infinity]) | 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. |
| Part A: Area Under the Serum Concentration Time Curve From Time 0 to Time of the Last Measurable Concentration (AUC [0-last]) | 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. |
| Part B: Number of Participants with Gastrointestinal Adverse Events as a Measure of Safety and Tolerability of JNJ-64565111 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A and Part B: Number of Participants with Antibodies to JNJ-64565111 | 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. |
| Part B: Area Under the Serum Concentration Versus Time Curve Over the Dosing Interval (AUCtau) | From Day 36 until Day 43 | AUCtau (measure of the serum drug exposure over the dosing interval) after the last dose of JNJ-64565111. |
| Part A and Part B: Number of Participants with Adverse Events | 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. |
| Part B: Number of Gastrointestinal Adverse Events Over Time Upon Multiple Dosing | Approximately up to 6 weeks | The number of gastrointestinal adverse events over time will be evaluated upon multiple dosing of JNJ-64565111. |
| Part B: Maximum Observed Serum Concentration of JNJ-64565111 (Cmax) | From Day 36 until Day 43 | Cmax (maximum observed serum analyte concentration) after last dose of JNJ-64565111. |
Countries
United States
Outcome results
None listed