Healthy VolunteerPhase 1NCT01815827
A Study of Single Dose Inclacumab in Japanese Healthy Volunteers Compared to Caucasian Healthy Volunteers
A Phase 1 study testing inclacumab in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United States.
Trial summary
This open-label, parallel group study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of inclacumab in Japanese healthy volunteers compared to Caucasian healthy volunteers. Subjects will receive a single intravenous dose of inclacumab. Follow-up will be for up to 197 days. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- inclacumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Feb 2014
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers, 18 to 55 years of age, inclusive Healthy status as defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
- Japanese subjects must have Japanese parents and grandparents who were born in Japan
- Caucasian subjects must have Caucasian parents and grandparents
- Body mass index (BMI) 18 - 30 kg/m2 inclusive
Who cannot join
- Clinically significant abnormalities in laboratory test results (including positive test for HIV, hepatitis B and/or C), vital signs or ECGs
- Any confirmed significant allergic reactions against any drug, or multiple allergies (non-active hay fever is acceptable)
- Smokes more than 5 cigarettes per day during the three months prior to study conduct
- Participation in an investigational drug or device study within 30 days or 5 half-lives prior to screening
- Positive test for drugs of abuse
- Any suspicion of or history of alcohol and/or other substance abuse or addiction
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of Inclacumab in Japanese Healthy Volunteers Compared to Caucasian Healthy Volunteers
This open-label, parallel group study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of inclacumab in Japanese healthy volunteers compared to Caucasian healthy volunteers. Subjects will receive a single intravenous dose of inclacumab. Follow-up will be for up to 197 days.
- Conditions
- Healthy Volunteer
- Being tested
- inclacumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inclacumabDrug
single intravenous doses
| Study group | Role | What they receive |
|---|---|---|
| Caucasian Healthy volunteers | Active comparator | Not described Receives: Drug: inclacumab |
| Japanese Healthy volunteers | Experimental | Not described Receives: Drug: inclacumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Area under the concentration-time curve (AUC)
Measured: up to 197 days
Pharmacokinetics: Maximum plasma concentration (Cmax)
Measured: up to 197 days
Secondary outcomes (3)
Pharmacodynamics: Blood platelet leukocytes aggregation (PLA)
Measured: up to 197 days
Pharmacodynamics: Plasma (free and total) soluble P-selectin
Measured: up to 197 days
Safety: Incidence of adverse events
Measured: approximately 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815827
- Sponsor's protocol ID
- BP28134
- Status last verified
- Nov 2016
- First submitted
- 19 Mar 2013
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Morrison M, Palermo G, Schmitt C. Lack of ethnic differences in the pharmacokinetics and pharmacodynamics of inclacumab in healthy Japanese and Caucasian subjects. Eur J Clin Pharmacol. 2015 Nov;71(11):1365-74. doi: 10.1007/s00228-015-1938-4. Epub 2015 Sep 12.
PubMed 26363899
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of Inclacumab in Japanese Healthy Volunteers Compared to Caucasian Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01815827
- Acronym / sponsor ID
- BP28134
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 Mar 2013 (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.
This open-label, parallel group study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of inclacumab in Japanese healthy volunteers compared to Caucasian healthy volunteers. Subjects will receive a single intravenous dose of inclacumab. Follow-up will be for up to 197 days.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caucasian Healthy volunteers | Active comparator | Drug: inclacumab |
| Japanese Healthy volunteers | Experimental | Drug: inclacumab |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female volunteers, 18 to 55 years of age, inclusive Healthy status as defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
- Japanese subjects must have Japanese parents and grandparents who were born in Japan
- Caucasian subjects must have Caucasian parents and grandparents
- Body mass index (BMI) 18 - 30 kg/m2 inclusive
Key exclusion criteria (7 listed)
- Clinically significant abnormalities in laboratory test results (including positive test for HIV, hepatitis B and/or C), vital signs or ECGs
- Any confirmed significant allergic reactions against any drug, or multiple allergies (non-active hay fever is acceptable)
- Smokes more than 5 cigarettes per day during the three months prior to study conduct
- Participation in an investigational drug or device study within 30 days or 5 half-lives prior to screening
- Positive test for drugs of abuse
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 |
|---|---|---|
| inclacumabsingle intravenous doses | Drug | Caucasian Healthy volunteers, Japanese Healthy volunteers |
Primary outcome
Pharmacokinetics: Area under the concentration-time curve (AUC)
Time frame: up to 197 days
Pharmacokinetics: Maximum plasma concentration (Cmax)
Time frame: up to 197 days
3 secondary outcomes
Pharmacodynamics: Blood platelet leukocytes aggregation (PLA)
Time frame: up to 197 days
Pharmacodynamics: Plasma (free and total) soluble P-selectin
Time frame: up to 197 days
Safety: Incidence of adverse events
Time frame: approximately 10 months
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 2 Nov 2016.
- Derived from this study: PubMed 26363899Morrison M, Palermo G, Schmitt C. Lack of ethnic differences in the pharmacokinetics and pharmacodynamics of inclacumab in healthy Japanese and Caucasian subjects. Eur J Clin Pharmacol. 2015 Nov;71(11):1365-74. doi: 10.1007/s00228-015-1938-4. Epub 2015 Sep 12.
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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.
Clinical Trials study director
Hoffmann-La Roche
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 testing inclacumab in people with Healthy Volunteer, run by Hoffmann-La Roche 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 4 inclusion and 7 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 2 Nov 2016. 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: Area under the concentration-time curve (AUC) (time frame: up to 197 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01815827, which also lists 1 linked publication.
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 2 Nov 2016.