AtazanavirPhase 1NCT01368783
Two Clinical Trials to Evaluate Pharmacokinetics of Unboosted and Boosted Atazanavir Used Alone or Co-administered With Tenofovir DF in Healthy Korean and Caucasian Male Volunteers
A Phase 1 study testing atazanavir, Atazanavir(ATZ) and Tenofovir(TDF) and Atazanavir(ATZ) + Ritonavir in people with Atazanavir, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Compared to those of Caucasians, the plasma levels of atazanavir (ATV) may be higher in Koreans with the same dosage regimen(s). If so, even unboosted ATV could be used with tenofovir DF (TDF) which lowers the concentration of ATV. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Atazanavir
- What is being tested?
- atazanavir, Atazanavir(ATZ) and Tenofovir(TDF) and Atazanavir(ATZ) + Ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to not given
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men aged 20 to 55 years old, with a weight more than 50 kg and with appropriate body mass index (BMI) values within 19-28 kg/m2.
- Agreed voluntarily to participate to the study and comply with the study protocol with written permission.
Who cannot join
- Has history of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
- Has history of hypersensitivity or clinically significant adverse drug reaction(s) to the study drugs, same class of the study drugs, or other drugs including aspirin and antibiotics.
- Drinks excessive caffeinated beverages (caffeine >10 units/day), alcohol beverages (alcohol >21 units/week) or smokes excessively (>20 cigarettes/day) or has history of alcoholism.
- Has been excluded by the researchers due to abnormal findings in screening EKG and/or blood tests
Trial locations and contacts
1 site in 1 country.
Kyun-Seop Bae, M.D., Ph. D. contact
South Korea1 site
Asan Medical Center
Songpa-gu, Seoul, 138-736
Kyun-Seop Bae, M.D., Ph. D., 82-2-3010-4622
About this study
Official title: Two Randomized, Open-labeled, Parallel Designed Multiple-dose Clinical Trials to Evaluate Pharmacokinetics of Ritonavir-unboosted and Ritonavir-boosted Atazanavir Used Alone or Co-administered With Tenofovir DF in Healthy Korean and Caucasian Male Volunteers
Compared to those of Caucasians, the plasma levels of atazanavir (ATV) may be higher in Koreans with the same dosage regimen(s). If so, even unboosted ATV could be used with tenofovir DF (TDF) which lowers the concentration of ATV. The investigators plan to investigate the pharmacokinetic features of ATV with or without TDF in healthy Korean and Caucasian volunteers and compare the ethnic differences.
- Conditions
- Atazanavir
- Being tested
- atazanavir, Atazanavir(ATZ) and Tenofovir(TDF), Atazanavir(ATZ) + Ritonavir, atazanavir(ATZ) + tenofovir(TDF) + ritonavir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atazanavirDrug
400 mg/day for 2 days
Atazanavir(ATZ) and Tenofovir(TDF)Drug
ATZ 400 mg with TDF/day for 2 days
Atazanavir(ATZ) + RitonavirDrug
ATZ 300 mg + Ritonavir 100 mg/day for 2 days
atazanavir(ATZ) + tenofovir(TDF) + ritonavirDrug
ATZ 300 mg + Ritonavir 100 mg with TDF/day for 2 days
| Study group | Role | What they receive |
|---|---|---|
| atazanavir | Experimental | 400 mg/day for 2 days Receives: Drug: atazanavir |
| Atazanavir and Tenofovir | Experimental | Not described Receives: Drug: Atazanavir(ATZ) and Tenofovir(TDF) |
| Atazanavir and Ritonavir | Experimental | Not described Receives: Drug: Atazanavir(ATZ) + Ritonavir |
| Atazanavir + tenofovir + ritonavir | Experimental | Not described Receives: Drug: atazanavir(ATZ) + tenofovir(TDF) + ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic analysis
maximum concentration at steady status(Cmax,ss)
Secondary outcomes (1)
Pharmacokinetic evaluation
Area under the time-concentration curve, at steady status, at tau(τ) (AUCτ,ss)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtazanavirStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368783
- Sponsor's protocol ID
- 2011-ATV
- Status last verified
- May 2011
- First submitted
- 7 Jun 2011
- Last updated
- 8 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Randomized, Open-labeled, Parallel Designed Multiple-dose Clinical Trials to Evaluate Pharmacokinetics of Ritonavir-unboosted and Ritonavir-boosted Atazanavir Used Alone or Co-administered With Tenofovir DF in Healthy Korean and Caucasian Male Volunteers
- ClinicalTrials.gov ID
- NCT01368783
- Acronym / sponsor ID
- 2011-ATV
- Conditions
- Atazanavir
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jun 2011
- First posted
- 8 Jun 2011 (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.
Compared to those of Caucasians, the plasma levels of atazanavir (ATV) may be higher in Koreans with the same dosage regimen(s). If so, even unboosted ATV could be used with tenofovir DF (TDF) which lowers the concentration of ATV. The investigators plan to investigate the pharmacokinetic features of ATV with or without TDF in healthy Korean and Caucasian volunteers and compare the ethnic differences.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| atazanavir | Experimental | Drug: atazanavir400 mg/day for 2 days |
| Atazanavir and Tenofovir | Experimental | Drug: Atazanavir(ATZ) and Tenofovir(TDF) |
| Atazanavir and Ritonavir | Experimental | Drug: Atazanavir(ATZ) + Ritonavir |
| Atazanavir + tenofovir + ritonavir | Experimental | Drug: atazanavir(ATZ) + tenofovir(TDF) + ritonavir |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men aged 20 to 55 years old, with a weight more than 50 kg and with appropriate body mass index (BMI) values within 19-28 kg/m2.
- Agreed voluntarily to participate to the study and comply with the study protocol with written permission.
Key exclusion criteria (4 listed)
- Has history of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
- Has history of hypersensitivity or clinically significant adverse drug reaction(s) to the study drugs, same class of the study drugs, or other drugs including aspirin and antibiotics.
- Drinks excessive caffeinated beverages (caffeine >10 units/day), alcohol beverages (alcohol >21 units/week) or smokes excessively (>20 cigarettes/day) or has history of alcoholism.
- Has been excluded by the researchers due to abnormal findings in screening EKG and/or blood tests
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 |
|---|---|---|
| atazanavir400 mg/day for 2 days | Drug | atazanavir |
| Atazanavir(ATZ) and Tenofovir(TDF)ATZ 400 mg with TDF/day for 2 days | Drug | Atazanavir and Tenofovir |
| Atazanavir(ATZ) + RitonavirATZ 300 mg + Ritonavir 100 mg/day for 2 days | Drug | Atazanavir and Ritonavir |
| atazanavir(ATZ) + tenofovir(TDF) + ritonavirATZ 300 mg + Ritonavir 100 mg with TDF/day for 2 days | Drug | Atazanavir + tenofovir + ritonavir |
Primary outcome
Pharmacokinetic analysis
maximum concentration at steady status(Cmax,ss)
1 secondary outcome
Pharmacokinetic evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
Related trials for Atazanavir
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Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV
Acquired Immune Deficiency Syndrome (AIDS), HIV Infections
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.
Kyun-Seop Bae, M.D., Ph. D. contact
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 atazanavir, Atazanavir(ATZ) and Tenofovir(TDF) and Atazanavir(ATZ) + Ritonavir in people with Atazanavir, run by Asan Medical Center at 1 site in South Korea.
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 4 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: status not confirmed, as of the sponsor's last update on 8 Jun 2011. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyun-Seop Bae, M.D., Ph. D. (82-2-3010-4622), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic analysis. 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 8 Jun 2011.