HIV InfectionsPhase 1NCT00334659
A Study to Investigate the Cardiovascular Safety of Apricitabine in Healthy Subjects
A Phase 1 study testing apricitabine in people with HIV Infections, run by Avexa at 1 site in United States.
Trial summary
The purpose of this study is to confirm that apricitabine does not induce any clinically significant effect upon electrocardiogram (ECG) parameters at doses consistent with the maximum exposure expected to occur in clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- apricitabine
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Aug 2006
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male subjects 18 - 65 years of age, inclusive.
- Body mass index (BMI) between 18-30 kg/m2, inclusive, and a total body weight > 50 kg.
- No clinically significant medical history.
- No clinically significant findings on complete physical examination, including blood pressure, pulse rate and 12-lead ECG.
- Normal clinical safety laboratory results at screening.
- Willing and able to sign an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study.
- Willing and able to stay in the clinic for the in-patient activities required by the protocol.
Who cannot join
- Evidence of clinically relevant pathology that could interfere with the study results or put the subject's safety at risk.
- Current or recurrent disease that may affect the action, absorption or disposition of the study treatment, or clinical or laboratory assessments.
- Current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, any medical disorder requiring treatment or that may make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study treatment or procedures.
- History of febrile illness within the 5 days prior to the first dose.
- Positive Hepatitis B surface antigen, Hepatitis C antibody or HIV test result at screening visit.
- Use of any prescription medication within 7 days or 5 half-lives (whichever is longer) prior to the first dose of trial medication or during the study. As an exception, acetaminophen may be used at doses of ≤ 1 g/day.
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- Use of any over-the-counter (OTC) medication within 7 days or 5 half-lives (whichever is longer) prior to or during the study. Herbal supplements (including herbal weight-loss or "metabolism booster" therapies) must be discontinued 28 days prior to the first dose of trial medication.
- Known or suspected intolerance or hypersensitivity to the study drugs, closely related compounds or any of their stated ingredients.
- Subjects with a history of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces [150 ml] of wine, 12 ounces [360 ml] of beer or 1.5 ounces [45 ml] of hard liquor) or illicit substance abuse within 6 months of screening.
- Positive screen for alcohol or drugs of abuse during screening visit or at study check-in.
- History or evidence of routine use of tobacco or nicotine-containing products in excess of 5 cigarettes per day (or equivalent).
- Participated in a clinical study involving an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to study drug administration.
- Blood donation of one pint or more within 56 days of the start of the study.
- Plasmapheresis or plasma donation within 30 days of the start of the study.
- Single 12-lead ECG demonstrating QTc > 450 msec at screen. A single repeat ECG may be done at the investigator's discretion.
- Any condition that in the opinion of the investigator would complicate or compromise the study, or the well-being of the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled, Positive Controlled, Randomized, Crossover Study to Investigate the Cardiovascular Safety of Apricitabine in Healthy Subjects
The purpose of this study is to confirm that apricitabine does not induce any clinically significant effect upon electrocardiogram (ECG) parameters at doses consistent with the maximum exposure expected to occur in clinical practice.
- Conditions
- HIV Infections
- Being tested
- apricitabine
- Keywords
- HIV-1 Infection
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apricitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
QTc at individual Day 7 post-dose Tmax as determined by concurrent pharmacokinetic (PK) analysis for apricitabine
Measured: day 7
The maximum Day 7 QTc increase from baseline observed between 1 to 4 hours post-dose, using time-matched ECG assessments
Measured: day 7
The average Day 7 QTc observed between 1 to 4 hours post-dose
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avexa
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Susan W Cox, PhD, Study director, Avexa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00334659
- Sponsor's protocol ID
- AVX-101
- Status last verified
- Jun 2011
- First submitted
- 6 Jun 2006
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Positive Controlled, Randomized, Crossover Study to Investigate the Cardiovascular Safety of Apricitabine in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00334659
- Acronym / sponsor ID
- AVX-101
- Conditions
- HIV Infections
- Keywords
- HIV-1 Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- AvexaIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 8 Jun 2006 (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 confirm that apricitabine does not induce any clinically significant effect upon electrocardiogram (ECG) parameters at doses consistent with the maximum exposure expected to occur in clinical practice.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy male subjects 18 - 65 years of age, inclusive.
- Body mass index (BMI) between 18-30 kg/m2, inclusive, and a total body weight > 50 kg.
- No clinically significant medical history.
- No clinically significant findings on complete physical examination, including blood pressure, pulse rate and 12-lead ECG.
- Normal clinical safety laboratory results at screening.
Key exclusion criteria (16 listed)
- Evidence of clinically relevant pathology that could interfere with the study results or put the subject's safety at risk.
- Current or recurrent disease that may affect the action, absorption or disposition of the study treatment, or clinical or laboratory assessments.
- Current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, any medical disorder requiring treatment or that may make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study treatment or procedures.
- History of febrile illness within the 5 days prior to the first dose.
- Positive Hepatitis B surface antigen, Hepatitis C antibody or HIV test result at screening visit.
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 |
|---|---|---|
| apricitabine | Drug | – |
Primary outcome
QTc at individual Day 7 post-dose Tmax as determined by concurrent pharmacokinetic (PK) analysis for apricitabine
Time frame: day 7
The maximum Day 7 QTc increase from baseline observed between 1 to 4 hours post-dose, using time-matched ECG assessments
Time frame: day 7
The average Day 7 QTc observed between 1 to 4 hours post-dose
Time frame: day 7
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 23 Jun 2011.
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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.
Susan W Cox, PhD study director
Avexa
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 apricitabine in people with HIV Infections, run by Avexa 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 7 inclusion and 16 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 23 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 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?
QTc at individual Day 7 post-dose Tmax as determined by concurrent pharmacokinetic (PK) analysis for apricitabine (time frame: day 7). The study lists 3 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 23 Jun 2011.