Healthy VolunteersPhase 1NCT01258777
A Study of the Pharmacokinetics of Golimumab in Japanese and Caucasian Male Subjects
A Phase 1 study of Healthy Volunteers, run by Centocor, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics of golimumab in Japanese and Caucasian Males. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Apr 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have no clinically relevant abnormalities
- non-smoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study
- Japanese subjects born in Japan, outside of Japan for no more than 5 years, and have Japanese parents and maternal and paternal grandparents, determined by subject's verbal report
- Japanese subjects must have a valid Japanese passport
- Caucasian subjects must have Caucasian parents.
Who cannot join
- Have or had a history of clinically significant, severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
- Have any underlying physical or psychological medical condition
- Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Evaluate the Safety and Pharmacokinetics of CNTO 148 Following Single Subcutaneous Administration to Healthy Japanese and Caucasian Subjects
The purpose of this study is to evaluate the pharmacokinetics of golimumab in Japanese and Caucasian Males.
Read the detailed description
This is a randomized (study medication assigned by chance), double-blind (both the physician and subject do not know the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), of golimumab (Simponi). The study population will consist of 24 healthy male Japanese subjects and 24 healthy male Caucasian subjects. Subjects will receive a single dose of either 200 mg or 400 mg golimumab or placebo. Subjects will be in the study for up to 16 weeks. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (eg, blood pressure), and the occurrence and severity of adverse events. A single dose of 200 mg or 400 mg golimumab, or placebo.
- Conditions
- Healthy Volunteers
- Being tested
- 400 mg golimumab or placebo, 200 mg golimumab or placebo
- Keywords
- Healthy volunteers, Japanese male, Caucasian male, Simponi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400 mg golimumab or placeboDrug
Single dose of 400 mg subcutaneously
200 mg golimumab or placeboDrug
Single dose of 200 mg subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | 200 mg golimumab or placebo Single dose of 200 mg subcutaneously Receives: Drug: 200 mg golimumab or placebo |
| 002 | Experimental | 400 mg golimumab or placebo Single dose of 400 mg subcutaneously Receives: Drug: 400 mg golimumab or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (study of what the body does to the drug) of golimumab in Japanese and Caucasian Male subjects
Measured: Week 12 (Day 78)
Determine the immune response of golimumab in Japanese and Caucasian Male subjects
Measured: Week 12 (Day 78)
Safety of golimumab in Japanese and Caucasian Male subjects
Measured: Week 12 (Day 78)
Tolerability of golimumab in Japanese and Caucasian Male subjects
Measured: Week 12 (Day 78)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study startOct 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centocor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Centocor, Inc. Clinical Trial, Study director, Centocor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258777
- Sponsor's protocol ID
- CR016345
- Status last verified
- Sep 2013
- First submitted
- 22 Nov 2010
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety and Pharmacokinetics of CNTO 148 Following Single Subcutaneous Administration to Healthy Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT01258777
- Acronym / sponsor ID
- CR016345
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteers, Japanese male, Caucasian male, Simponi
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Centocor, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Study completion
- Apr 2011 (actual)
- First posted
- 13 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the pharmacokinetics of golimumab in Japanese and Caucasian Males.
Detailed description
This is a randomized (study medication assigned by chance), double-blind (both the physician and subject do not know the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), of golimumab (Simponi). The study population will consist of 24 healthy male Japanese subjects and 24 healthy male Caucasian subjects. Subjects will receive a single dose of either 200 mg or 400 mg golimumab or placebo. Subjects will be in the study for up to 16 weeks. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (eg, blood pressure), and the occurrence and severity of adverse events. A single dose of 200 mg or 400 mg golimumab, or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: 200 mg golimumab or placebo200 mg golimumab or placebo Single dose of 200 mg subcutaneously |
| 002 | Experimental | Drug: 400 mg golimumab or placebo400 mg golimumab or placebo Single dose of 400 mg subcutaneously |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Have no clinically relevant abnormalities
- non-smoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study
- Japanese subjects born in Japan, outside of Japan for no more than 5 years, and have Japanese parents and maternal and paternal grandparents, determined by subject's verbal report
- Japanese subjects must have a valid Japanese passport
- Caucasian subjects must have Caucasian parents.
Key exclusion criteria (3 listed)
- Have or had a history of clinically significant, severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
- Have any underlying physical or psychological medical condition
- Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 400 mg golimumab or placeboSingle dose of 400 mg subcutaneously | Drug | 002 |
| 200 mg golimumab or placeboSingle dose of 200 mg subcutaneously | Drug | 001 |
Primary outcome
Pharmacokinetics (study of what the body does to the drug) of golimumab in Japanese and Caucasian Male subjects
Time frame: Week 12 (Day 78)
Determine the immune response of golimumab in Japanese and Caucasian Male subjects
Time frame: Week 12 (Day 78)
Safety of golimumab in Japanese and Caucasian Male subjects
Time frame: Week 12 (Day 78)
Tolerability of golimumab in Japanese and Caucasian Male subjects
Time frame: Week 12 (Day 78)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Centocor, Inc. Clinical Trial study director
Centocor, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Healthy Volunteers, run by Centocor, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (study of what the body does to the drug) of golimumab in Japanese and Caucasian Male subjects (time frame: Week 12 (Day 78)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2013.