A Study of JNJ-64565111 After Single Subcutaneous Administration at Different Injection Sites in Otherwise Healthy Overweight/Obese Adult Participants and a Study of JNJ-6456511 in Otherwise Healthy Obese Adult Participants After Multiple Dose

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: JNJ-64565111

Study type: Interventional

Funder types: Industry

Identifiers

NCT03586843

CR108509

64565111OBE1001 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 52 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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52 participants in 7 patient groups

Part A: Treatment Sequence ABC: JNJ-64565111

Experimental group

Description:

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.

Treatment:

Drug: JNJ-64565111

Part A: Treatment Sequence ACB: JNJ-64565111

Experimental group

Description:

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.

Treatment:

Drug: JNJ-64565111

Part A: Treatment Sequence BAC: JNJ-64565111

Experimental group

Description:

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.

Treatment:

Drug: JNJ-64565111

Part A: Treatment Sequence BCA: JNJ-64565111

Experimental group

Description:

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.

Treatment:

Drug: JNJ-64565111

Part A: Treatment Sequence CAB: JNJ-64565111

Experimental group

Description:

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.

Treatment:

Drug: JNJ-64565111

Part A: Treatment Sequence CBA: JNJ-64565111

Experimental group

Description:

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.

Treatment:

Drug: JNJ-64565111

Part B: JNJ-64565111

Experimental group

Description:

Participants will receive a single SC ascending doses of JNJ-64565111 on Days 1, 8, 15, 22, 29 and 36.

Treatment:

Drug: JNJ-64565111