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

NCT02224118 | Completed Phase 1

• 2 other identifiers: CR016429JNS030-JPN-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the safety (adverse events, weight, blood pressure, pulse rate, body temperature, abdominal ultrasonography, standard 12-lead electrocardiography, and laboratory tests) of CNTO 3649 when administered once by subcutaneous injection in healthy adult Japanese men or once a week for 4 weeks in Japanese participants with type 2 diabetes mellitus (disorder in which there is decreased insulin in the body or the body's insulin is not effective, resulting in high blood sugar, increased thirst and urine, and many other side effects).

Conditions

Healthy; Diabetes Mellitus, Type 2

Keywords

Healthy; Diabetes Mellitus, Type 2; CNTO 3649

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

  An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to 57 for CNTO 3649 10, 30, 100 and 300 microgram per kilogram (mcg/kg) (Part 1); Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2) that would be absent before treatment or that may worsen relative to pre-treatment state.

  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 Outcomes (11)

• Maximum Observed Serum Concentration (Cmax)

  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)

  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)

  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 Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - last])

  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])

  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)

Study Arms (7)

CNTO 3649 10 mcg/kg (single dose)

EXPERIMENTAL

A single dose of 10 microgram per kilogram (mcg/kg) of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men.

Drug: CNTO 3649 10 mcg/kg

CNT0 3649 30 mcg/kg (single dose)

EXPERIMENTAL

A single dose of 30 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men.

Drug: CNT0 3649 30 mcg/kg

CNTO 3649 100 mcg/kg (single dose)

EXPERIMENTAL

A single dose of 100 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men.

Drug: CNTO 3649 100 mcg/kg

CNTO 3649 300 mcg/kg (single dose)

EXPERIMENTAL

A single dose of 300 microgram per kilogram (mcg/kg) of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men.

Drug: CNTO 3649 300 mcg/kg

CNT0 3649 30 mcg/kg (multiple dose)

EXPERIMENTAL

Participants with type 2 diabetes mellitus will be administered 30 mcg/kg CNTO 3649 as subcutaneous injection once a week for 4 weeks.

Drug: CNT0 3649 30 mcg/kg

CNTO 3649 100 mcg/kg (multiple dose)

EXPERIMENTAL

Participants with type 2 diabetes mellitus will be administered 100 mcg/kg CNTO 3649 as subcutaneous injection once a week for 4 weeks.

Drug: CNTO 3649 100 mcg/kg

Placebo

PLACEBO COMPARATOR

Matching placebo to CNTO 3649 will be administered to both healthy volunteers and participants with type 2 diabetes mellitus.

Drug: Placebo

Interventions

CNTO 3649 10 mcg/kg DRUG

A single dose of 10 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men.

CNTO 3649 10 mcg/kg (single dose)

CNT0 3649 30 mcg/kg DRUG

A single dose of 30 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men and multiple doses of 30 mcg/kg of CNTO 3649 will be administered to participants with type 2 diabetes mellitus as subcutaneous injections once weekly for 4 weeks.

CNT0 3649 30 mcg/kg (multiple dose); CNT0 3649 30 mcg/kg (single dose)

CNTO 3649 100 mcg/kg DRUG

A single dose of 100 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men and multiple doses of 100 mcg/kg of CNTO 3649 will be administered to participants with type 2 diabetes mellitus as subcutaneous injections once weekly for 4 weeks.

CNTO 3649 100 mcg/kg (multiple dose); CNTO 3649 100 mcg/kg (single dose)

CNTO 3649 300 mcg/kg DRUG

A single dose of 300 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men.

CNTO 3649 300 mcg/kg (single dose)

Placebo DRUG

Matching Placebo to CNTO 3649 will be administered to both healthy volunteers and participants with type 2 diabetes mellitus.

Placebo

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (1)

Unknown Facility

Fukukoka, Japan

Location

Related Links

• 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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 25, 2014
• Study Start: July 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: September 9, 2014

Record last verified: 2014-09

Locations

JP (1)