Human Immunodeficiency Virus (HIV) InfectionPhase 1NCT00821535
Investigation Of Safety And Pharmacokinetics Following A Single Oral Dose Of 300 Mg Maraviroc In Healthy Male Japanese Volunteers
A Phase 1 study testing maraviroc (Selzentry, Celsentri) in people with Human Immunodeficiency Virus (HIV) Infection, run by ViiV Healthcare at 1 site in Singapore.
Trial summary
To confirm safety and pharmacokinetics of maraviroc following a single oral dose of 300 mg maraviroc in healthy male Japanese volunteers. Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus (HIV) Infection
- What is being tested?
- maraviroc (Selzentry, Celsentri)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSingapore
- Study dates
- Feb 2009to May 2009
- 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 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male Japanese subjects between the ages of 21 and 50 years inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Positive result for HIV, Hepatitis B surface antigen (HbsAg) or HCV antibody.
- Hypersensitivity/allergic reactions to any component of maraviroc, including soy lecithin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Single Dose Study To Investigate Safety And Pharmacokinetics Of Maraviroc Following A Single Oral Dose Of 300 Mg Maraviroc (Two 150 Mg Maraviroc Commercial Tablets) Under Fasting Conditions In Healthy Male Japanese Volunteers
To confirm safety and pharmacokinetics of maraviroc following a single oral dose of 300 mg maraviroc in healthy male Japanese volunteers.
- Being tested
- maraviroc (Selzentry, Celsentri)
- Keywords
- pharmacokinetics, Japanese, healthy volunteer, maraviroc
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maraviroc (Selzentry, Celsentri)Drug
Also called Selzentry, Celsentri
12 subjects will receive a single dose of 300 mg maraviroc (two 150 mg maraviroc commercial tablets) under fasting conditions.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Other | maraviroc dosing group Receives: Drug: maraviroc (Selzentry, Celsentri) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma and urine maraviroc concentrations for pharmacokinetic analysis
Measured: pre-48 hrs post dose
Adverse event monitoring
Measured: Day 0 to Day 3
Bood pressure, pulse rate
Measured: Day 0, Day 1, and Day 3
Blood and urine safety laboratory tests
Measured: Day 0 and Day 3
ECG
Measured: Day 0 and Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV) InfectionStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821535
- Sponsor's protocol ID
- A4001084
- Status last verified
- Nov 2010
- First submitted
- 12 Jan 2009
- Last updated
- 16 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Single Dose Study To Investigate Safety And Pharmacokinetics Of Maraviroc Following A Single Oral Dose Of 300 Mg Maraviroc (Two 150 Mg Maraviroc Commercial Tablets) Under Fasting Conditions In Healthy Male Japanese Volunteers
- ClinicalTrials.gov ID
- NCT00821535
- Acronym / sponsor ID
- A4001084
- Keywords
- pharmacokinetics, Japanese, healthy volunteer, maraviroc
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Feb 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 13 Jan 2009 (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.
To confirm safety and pharmacokinetics of maraviroc following a single oral dose of 300 mg maraviroc in healthy male Japanese volunteers.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active group | Other | Drug: maraviroc (Selzentry, Celsentri)maraviroc dosing group |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male Japanese subjects between the ages of 21 and 50 years inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg.
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Positive result for HIV, Hepatitis B surface antigen (HbsAg) or HCV antibody.
- Hypersensitivity/allergic reactions to any component of maraviroc, including soy lecithin.
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 |
|---|---|---|
| maraviroc (Selzentry, Celsentri)Also: Selzentry, Celsentri12 subjects will receive a single dose of 300 mg maraviroc (two 150 mg maraviroc commercial tablets) under fasting conditions. | Drug | Active group |
Primary outcome
Plasma and urine maraviroc concentrations for pharmacokinetic analysis
Time frame: pre-48 hrs post dose
Adverse event monitoring
Time frame: Day 0 to Day 3
Bood pressure, pulse rate
Time frame: Day 0, Day 1, and Day 3
Blood and urine safety laboratory tests
Time frame: Day 0 and Day 3
ECG
Time frame: Day 0 and Day 3
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 16 Nov 2010.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 maraviroc (Selzentry, Celsentri) in people with Human Immunodeficiency Virus (HIV) Infection, run by ViiV Healthcare at 1 site in Singapore.
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 2 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 16 Nov 2010. 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 Singapore. 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?
Plasma and urine maraviroc concentrations for pharmacokinetic analysis (time frame: pre-48 hrs post dose). The study lists 5 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 16 Nov 2010.