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| ID | Type | Description | Link |
|---|---|---|---|
| 64565111OBE1001 | Other Identifier | Janssen Research & Development, LLC |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Treatment Sequence ABC: JNJ-64565111 | Experimental | Participants will receive Treatment A (JNJ-64565111 subcutaneous [SC] administration in the upper arm in fasted condition) on Day 1 of Treatment Period 1; followed by Treatment B (JNJ-64565111 SC administration in the thigh in fasted condition) on Day 1 of Treatment Period 2 and then Treatment C (JNJ-64565111 SC administration in the abdomen in fasted condition) on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last pharmacokinetic (PK) sample collection and dosing on Day 1 of subsequent treatment period. |
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| Part A: Treatment Sequence ACB: JNJ-64565111 | Experimental | Participants will receive Treatment A on Day 1 of Treatment Period 1; followed by Treatment C on Day 1 of Treatment Period 2 and then Treatment B on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last PK sample collection and dosing on Day 1 of subsequent treatment period. |
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| Part A: Treatment Sequence BAC: JNJ-64565111 | Experimental | Participants will receive Treatment B on Day 1 of Treatment Period 1; followed by Treatment A on Day 1 of Treatment Period 2 and then Treatment C on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last PK sample collection and dosing on Day 1 of subsequent treatment period. |
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| Part A: Treatment Sequence BCA: JNJ-64565111 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-64565111 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Maximum Observed Serum Concentration of JNJ-64565111 (Cmax) | Cmax is the maximum observed serum analyte concentration. | 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.](streamdown:incomplete-link) | 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. | 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. | Approximately up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Part A and Part B: Number of Participants with Antibodies to JNJ-64565111 | Number of participants with antibodies to JNJ-64565111 will be reported. | 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) |
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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:
Part B:
Exclusion Criteria:
Part A and Part B:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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Participants will receive Treatment B on Day 1 of Treatment Period 1; followed by Treatment C on Day 1 of Treatment Period 2 and then Treatment A on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last PK sample collection and dosing on Day 1 of subsequent treatment period. |
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| Part A: Treatment Sequence CAB: JNJ-64565111 | Experimental | Participants will receive Treatment C on Day 1 of Treatment Period 1; followed by Treatment A on Day 1 of Treatment Period 2 and then Treatment B on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last PK sample collection and dosing on Day 1 of subsequent treatment period. |
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| Part A: Treatment Sequence CBA: JNJ-64565111 | Experimental | Participants will receive Treatment C on Day 1 of Treatment Period 1; followed by Treatment B on Day 1 of Treatment Period 2 and then Treatment A on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last PK sample collection and dosing on Day 1 of subsequent treatment period. |
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| Part B: JNJ-64565111 | Experimental | Participants will receive a single SC ascending doses of JNJ-64565111 on Days 1, 8, 15, 22, 29 and 36. |
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| 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. | 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. | 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. | 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. | From Day 36 until Day 43 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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