Safety, Pharmacokinetics, and Pharmacodynamics Study of Single Dose of CNTO 3649 in Healthy Adult Men and Multiple Doses of CNTO 3649 in Participants With Type 2 Diabetes Mellitus

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02224118
• Date of registration: 21/08/2014
• Prospective Registration: No
• Primary sponsor: Janssen Pharmaceutical K.K.
• Public title: Safety, Pharmacokinetics, and Pharmacodynamics Study of Single Dose of CNTO 3649 in Healthy Adult Men and Multiple Doses of CNTO 3649 in Participants With Type 2 Diabetes Mellitus
• Scientific title: Safety, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Dose of CNTO 3649 in Healthy Adult Men and Multiple Subcutaneous Doses of CNTO 3649 in Patients With Type 2 Diabetes Mellitus
• Date of first enrolment: July 2009
• Target sample size: 64
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02224118
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Japan

Contacts

• Name: Janssen Pharmaceutical K.K., Japan Clinical Trial
• Affiliation: Janssen Pharmaceutical K.K.

Key inclusion & exclusion criteria

Inclusion Criteria:

Part 1

- Weighs greater than or equal to (>=) 50 kilogram (kg) and less than (<) 100 kg and
has a body mass index (BMI) of >= 18.5 and <25.0 at the time of screening tests

- Is a non-smoker, or is able to refrain from smoking from 2 days before
screening tests until completion of post-treatment examinations or follow-up
investigations

- Is able to refrain from consuming alcohol from 2 days before screening tests until
completion of screening tests, from 2 days before hospitalization (Day -4)
until after discharge (Day 8), from 2 days before clinic visits (Days 13 and 20)
until completion of tests at clinic visits (Days 15 and 22), and from 2 days
before post-treatment examinations or follow-up investigations until completion
of post-treatment examinations or follow-up investigations

- Has agreed to use a medically acceptable form of contraception (example [eg],
condoms) from the day of hospitalization (Day -2) until completion of
post-treatment examinations or follow-up investigations

- Has no clinically problematic abnormalities in medical examinations and tests before
study treatment

Part 2

- Weighs >= 50 kg and <100 kg and has a BMI of >=18.5 and <37.0 at the time of
screening tests

- Was diagnosed with type 2 diabetes mellitus at least 3 months before screening tests
and this is being stably managed with dietary modification, exercise therapy, or
sulfonylureas or biguanides If sulfonylureas or biguanides are being used, these
have been used at a fixed dosage to stably manage the disease since at least 3
months before screening tests

- If the participant has hyperlipidemia, this has been stably managed with
antihyperlipidemic drugs at a fixed dosage since at least 3 months before screening
tests

- If the participant has hypertension, this has been stably managed with
antihypertensive drugs at a fixed dosage since at least 3 months before screening
tests

- Is a non-smoker, or is able to refrain from smoking during the
hospitalization period and from 1 day before clinic visit days until completion of
tests

Exclusion Criteria:

Part 1

- Has or has had hepatic, renal, central nervous system (including psychiatric),
cardiovascular, respiratory, gastrointestinal, hematopoietic, ophthalmic, infectious,
or endocrine disease that would make the participant unsuitable as a study
participant

- Has had a malignant tumor within 5 years before study treatment

- Has undergone surgery that would make the participant unsuitable as a study
participant within 12 weeks before screening tests

- Has or had acute disease that occurred within 7 days before study treatment

- Has or has had an eating disorder (pathological anorexia or bulimia)

Part 2

- If only dietary modification and exercise therapy are being used, fasting
blood glucose is <130 milligram per deciliters (mg/dL) or >= 270 mg/dL in
screening tests and at hospitalization (Day -1). If oral antihyperglycemic
drugs are being used, fasting blood glucose is <100 mg/dL or >= 240 mg/dL at the time
of screening tests and <120 mg/dL or >= 270 mg/dL at hospitalization (Day -1)

- If only dietary modification and exercise therapy are being used, HbA 1C at the time
of Screening tests is <6% or >= 10 percent (%). If oral antihyperglycemic drugs are
being used, HbA 1C at the time of screening tests is <6% or >=9%

- Has blood pressure or a pulse rate that is outside of the following ranges, or has
hypertension and blood pressure or a pulse rate that is outside of the following
ranges despite taking an antihypertensive drug at the same dosage since at least 3
months before screening tests

- Has or has had type 1 diabetes mellitus

- Has or has had autoimmune diabetes mellitus



Age minimum: 20 Years
Age maximum: 64 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Healthy

Intervention(s)

Drug: Placebo

Drug: CNT0 3649 30 mcg/kg

Drug: CNTO 3649 10 mcg/kg

Drug: CNTO 3649 300 mcg/kg

Drug: CNTO 3649 100 mcg/kg

Primary Outcome(s)

Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [Time Frame: Day 1 to 57 for CNTO 3649 10, 30, 100 and 300 mcg/kg (Part 1) or Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2)]

Secondary Outcome(s)

Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - last]) [Time Frame: Day 1 to 57 for CNTO 3649 10, 30, 100 and 300 mcg/kg (Part 1) or Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2)]

Apparent Systemic Clearance (CL/F) [Time Frame: Day 1 to 57 for CNTO 3649 10, 30, 100 and 300 mcg/kg (Part 1) or Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2)]

Maximum Observed Serum Concentration (Cmax) [Time Frame: Day 1 to 57 for CNTO 3649 10, 30, 100 and 300 mcg/kg (Part 1) or Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2)]

Area Under the Concentration-time Curve From Zero to Infinity (AUC [0 - infinity]) [Time Frame: Day 1 to 57 for CNTO 3649 10, 30, 100 and 300 mcg/kg (Part 1) or Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2)]

Terminal Phase Elimination Half Life (t1/2) [Time Frame: Day 1 to 57 for CNTO 3649 10, 30, 100 and 300 mcg/kg (Part 1) or Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2)]

Time to Reach Maximum Observed Serum Concentration (Tmax) [Time Frame: Day 1 to 57 for CNTO 3649 10, 30, 100 and 300 mcg/kg (Part 1) or Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2)]

Weighted Average Blood Glucose (WAG) Level [Time Frame: Day -1 (Predose) and 24]

Apparent Volume of Distribution (Vz/F) [Time Frame: Day 1 to 57 for CNTO 3649 10, 30, 100 and 300 mcg/kg (Part 1) or Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2)]

Change From Baseline in Glycosylated Haemoglobin (Hb) A1c at Day 36 and 50 [Time Frame: Baseline, Day 36 and 50]

Number of Participants Exhibiting Anti-Drug Antibodies for CNTO 3649 at any Visit [Time Frame: Day 1 to 57 for CNTO 3649 10, 30, 100 and 300 mcg/kg (Part 1) or Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2)]

Mean Percentage Change From Baseline in Blood Glucose Values, Serum Insulin Concentration, and Serum C-Peptide Concentration [Time Frame: Day 1 to 57 for CNTO 3649 10, 30, 100 and 300 mcg/kg (Part 1) or Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2)]

Secondary ID(s)

CR016429

JNS030-JPN-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors