Healthy SubjectsPhase 1NCT01366547
Relative Bioavailability Study of Two New Dolutegravir/Abacavir/Lamivudine Fixed Dose Combination Tablets
A Phase 1 study testing Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg, Dolutegravir 50 mg and abacavir 600 mg/lamivudine 300 mg in people with Healthy Subjects and Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 1 site in United States.
Trial summary
Dolutegravir (DTG, GSK1349572) is a next-generation integrase inhibitor (INI) currently in phase 3 clinical trials for human immunodeficiency virus (HIV). Fixed-dose combinations (FDCs) have greatly simplified the treatment of patients with HIV. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Infection, Human Immunodeficiency Virus
- What is being tested?
- Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg, Dolutegravir 50 mg and abacavir 600 mg/lamivudine 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jul 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of: Non-childbearing potential or child-bearing potential and agrees to use one of the contraception methods listed in the protocol until the follow-up visit.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the protocol until 84 days after the last dose of study drug.
- Body weight greater than 50 kg for males and greater than 45 kg for females and BMI within the range 18.5- 31.0 kg/m2 (inclusive).
- ALT, alkaline phosphatase and bilirubin less than 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- A negative HLA-B*5701 allele screening assessment
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- If heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
- History of regular alcohol consumption within 6 months of the study defined as:An average weekly intake of >14 drinks/week for men or >7 drinks/week for women. 7. Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
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- Pregnant females as determined by positive serum or urine human chorionic gonadotrophin (hCG) test at screening or prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs. Subjects with a history of cholecystectomy, peptic ulceration, inflammatory bowel disease or pancreatitis should be excluded.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- A positive test for HIV antibody.
- History of Gilbert's disease.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- The subject's systolic blood pressure is outside the range of 90-140mmHg, or diastolic blood pressure is outside the range of 45-90mmHg or heart rate is outside the range of 50-100bpm for female subjects or 45-100 bpm for male subjects.
- Exclusion criteria for screening ECG outside of protocol limits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Single-Dose, 3-Period, Crossover Evaluation of the Relative Bioavailability of Two Experimental Fixed-Dose Combination Tablet Formulations of Dolutegravir 50 mg/Abacavir 600 mg/Lamivudine 300 mg Compared to Co-Administered Dolutegravir 50 mg and EPZICOM™ (Abacavir 600 mg/Lamivudine 300 mg) Tablets in Healthy Adult Subjects
Dolutegravir (DTG, GSK1349572) is a next-generation integrase inhibitor (INI) currently in phase 3 clinical trials for human immunodeficiency virus (HIV). Fixed-dose combinations (FDCs) have greatly simplified the treatment of patients with HIV. While Atripla (an FDC of tenofovir (TDF), emtricitabine (FTC) and efavirenz (EFV)) has become the preferred first line regimen due in large part to its convenient presentation as a full treatment regimen in a single product, other options are needed. A fixed-dose combination of DTG/abacavir (ABC)/lamivudine (3TC) is one such opportunity.
This is a single-center, randomized, open-label, 3-period crossover study in healthy adult subjects to evaluate the single-dose relative bioavailability of two experimental oral DTG 50 mg/ABC 600 mg/3TC 300 mg FDC tablet formulations compared to co-administration of the separate tablet formulations (DTG 50 mg tablet and EPZICOM), with each dose administered in the fasted state. Approximately 18 subjects will be enrolled and randomized to one of 6 different treatment sequences. There will be a screening visit within 30 days prior to the first dose of study drug and a follow up visit within 7-14 days after the last dose. There will be a 7 day washout between doses in each treatment period.
The following PK parameters for DTG, ABC and 3TC will be measured: area under the concentration curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity)), Area under the concentration-time curve from time zero (pre-dose) to the time of the last quantifiable concentration (AUC (0-t)), maximum observed concentration (Cmax), lag time before observation of drug concentrations (tlag), time of occurrence of Cmax (tmax), terminal phase half-life (t½), apparent clearance following oral dosing (CL/F) and apparent terminal phase volume of distribution (Vz/F).
Read the detailed description
Official Title - Randomized, Open-Label, Single Dose, 3 Period, Crossover Evaluation of the Relative Bioavailability of Two Experimental Fixed-Dose Combination Tablet Formulations of Dolutegravir 50 mg/Abacavir 600 mg/Lamivudine 300 mg Compared to Co administered Dolutegravir 50 mg and EPZICOM™ (Abacavir 600 mg/Lamivudine 300 mg) Tablets in Healthy Adult Subjects.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship
- Being tested
- Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg, Dolutegravir 50 mg, abacavir 600 mg/lamivudine 300 mg
- Keywords
- Bioavailability, Lamivudine, Dolutegravir, integrase, Abacavir
- Medical subject headings
- Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mgDrug
Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg is an experimental fixed dose combination tablet of an experimental integrase inhibitor (dolutegravir) and two FDA approved nucleoside reverse transcriptase inhibitors (abacavir and lamivudine)
Dolutegravir 50 mgDrug
Dolutegravir is an experimental drug in the integrase inhibitor class that is being studied for the treatment of HIV infection.
abacavir 600 mg/lamivudine 300 mgDrug
Also called KIVEXA. This is a trademark of ViiV Healthcare, EPZICOM. This is a trademark of ViiV Healthcare.
This is an FDA approved fixed dose combination tablet of two nucleoside reverse transcriptase inhibitors
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Subjects will be randomized in a three-way crossover design to receive a single dose of each of two different tablet formulations of dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg or dolutegravir 50 mg plus EPZICOM (abacavir 600mg/lamivudine 300 mg). There will be a screening visit within 30 days prior to first dose and a follow-up visit 7-14 days after the last dose. Receives: Drug: Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg; Drug: Dolutegravir 50 mg; Drug: abacavir 600 mg/lamivudine 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma DTG AUC(0-infinity)
Measured: 48 hours post dose
Plasma ABC AUC(0-infinity)
Measured: 48 hours post dose
Plasma 3TC AUC(0-infinity)
Measured: 48 hours post dose
Plasma DTG AUC(0-t)
Measured: 48 hours post dose
Plasma ABC AUC(0-t)
Measured: 48 hours post dose
Plasma 3TC AUC(0-t)
Measured: 48 hours post dose
Plasma DTG Cmax
Measured: 48 hours post dose
Plasma ABC Cmax
Measured: 48 hours post dose
Plasma 3TC Cmax
Measured: 48 hours post dose
Secondary outcomes (19)
Change from baseline in 12-lead ECG
Measured: 48 hours post dose
Plasma DTG tlag
Measured: 48 hours post dose
Number of subjects with adverse events
Measured: 48 hours post dose
Toxicity grading of clinical laboratory tests
Measured: 48 hours post dose
Change from baseline in vital signs (BP and HR)
Measured: 48 hours post dose
Plasma ABC tlag
Measured: 48 hours post dose
Plasma 3TC tlag
Measured: 48 hours post dose
Plasma DTG tmax
Measured: 48 hours post dose
Plasma ABC tmax
Measured: 48 hours post dose
Plasma 3TC tmax
Measured: 48 hours post dose
Plasma DTG t½
Measured: 48 hours post dose
Plasma ABC t½
Measured: 48 hours post dose
Plasma 3TC t½
Measured: 48 hours post dose
Plasma DTG CL/F
Measured: 48 hours post dose
Plasma ABC CL/F
Measured: 48 hours post dose
Plasma 3TC CL/F
Measured: 48 hours post dose
Plasma DTG Vz/F
Measured: 48 hours post dose
Plasma ABC Vz/F
Measured: 48 hours post dose
Plasma 3TC Vz/F
Measured: 48 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shionogi, GlaxoSmithKline
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366547
- Sponsor's protocol ID
- 114581
- Status last verified
- Aug 2011
- First submitted
- 26 May 2011
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Single-Dose, 3-Period, Crossover Evaluation of the Relative Bioavailability of Two Experimental Fixed-Dose Combination Tablet Formulations of Dolutegravir 50 mg/Abacavir 600 mg/Lamivudine 300 mg Compared to Co-Administered Dolutegravir 50 mg and EPZICOM™ (Abacavir 600 mg/Lamivudine 300 mg) Tablets in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01366547
- Acronym / sponsor ID
- 114581
- Keywords
- Bioavailability, Lamivudine, Dolutegravir, integrase, Abacavir
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Shionogi, GlaxoSmithKline
- Study start
- Jun 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 6 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.
Dolutegravir (DTG, GSK1349572) is a next-generation integrase inhibitor (INI) currently in phase 3 clinical trials for human immunodeficiency virus (HIV). Fixed-dose combinations (FDCs) have greatly simplified the treatment of patients with HIV. While Atripla (an FDC of tenofovir (TDF), emtricitabine (FTC) and efavirenz (EFV)) has become the preferred first line regimen due in large part to its convenient presentation as a full treatment regimen in a single product, other options are needed. A fixed-dose combination of DTG/abacavir (ABC)/lamivudine (3TC) is one such opportunity.
This is a single-center, randomized, open-label, 3-period crossover study in healthy adult subjects to evaluate the single-dose relative bioavailability of two experimental oral DTG 50 mg/ABC 600 mg/3TC 300 mg FDC tablet formulations compared to co-administration of the separate tablet formulations (DTG 50 mg tablet and EPZICOM), with each dose administered in the fasted state. Approximately 18 subjects will be enrolled and randomized to one of 6 different treatment sequences. There will be a screening visit within 30 days prior to the first dose of study drug and a follow up visit within 7-14 days after the last dose. There will be a 7 day washout between doses in each treatment period.
The following PK parameters for DTG, ABC and 3TC will be measured: area under the concentration curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity)), Area under the concentration-time curve from time zero (pre-dose) to the time of the last quantifiable concentration (AUC (0-t)), maximum observed concentration (Cmax), lag time before observation of drug concentrations (tlag), time of occurrence of Cmax (tmax), terminal phase half-life (t½), apparent clearance following oral dosing (CL/F) and apparent terminal phase volume of distribution (Vz/F).
Detailed description
Official Title - Randomized, Open-Label, Single Dose, 3 Period, Crossover Evaluation of the Relative Bioavailability of Two Experimental Fixed-Dose Combination Tablet Formulations of Dolutegravir 50 mg/Abacavir 600 mg/Lamivudine 300 mg Compared to Co administered Dolutegravir 50 mg and EPZICOM™ (Abacavir 600 mg/Lamivudine 300 mg) Tablets in Healthy Adult Subjects.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg, Drug: Dolutegravir 50 mg, Drug: abacavir 600 mg/lamivudine 300 mgSubjects will be randomized in a three-way crossover design to receive a single dose of each of two different tablet formulations of dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg or dolutegravir 50 mg plus EPZICOM (abacavir 600mg/lamivudine 300 mg). There will be a screening visit within 30 days prior to first dose and a follow-up visit 7-14 days after the last dose. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of: Non-childbearing potential or child-bearing potential and agrees to use one of the contraception methods listed in the protocol until the follow-up visit.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the protocol until 84 days after the last dose of study drug.
- Body weight greater than 50 kg for males and greater than 45 kg for females and BMI within the range 18.5- 31.0 kg/m2 (inclusive).
Key exclusion criteria (16 listed)
- The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- If heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
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 |
|---|---|---|
| Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mgDolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg is an experimental fixed dose combination tablet of an experimental integrase inhibitor (dolutegravir) and two FDA approved nucleoside reverse transcriptase inhibitors (abacavir and lamivudine) | Drug | Single Arm |
| Dolutegravir 50 mgDolutegravir is an experimental drug in the integrase inhibitor class that is being studied for the treatment of HIV infection. | Drug | Single Arm |
| abacavir 600 mg/lamivudine 300 mgAlso: KIVEXA. This is a trademark of ViiV Healthcare, EPZICOM. This is a trademark of ViiV Healthcare.This is an FDA approved fixed dose combination tablet of two nucleoside reverse transcriptase inhibitors | Drug | Single Arm |
Primary outcome
Plasma DTG AUC(0-infinity)
Time frame: 48 hours post dose
Plasma ABC AUC(0-infinity)
Time frame: 48 hours post dose
Plasma 3TC AUC(0-infinity)
Time frame: 48 hours post dose
Plasma DTG AUC(0-t)
Time frame: 48 hours post dose
Plasma ABC AUC(0-t)
Time frame: 48 hours post dose
Plasma 3TC AUC(0-t)
Time frame: 48 hours post dose
Plasma DTG Cmax
Time frame: 48 hours post dose
Plasma ABC Cmax
Time frame: 48 hours post dose
Plasma 3TC Cmax
Time frame: 48 hours post dose
19 secondary outcomes
Change from baseline in 12-lead ECG
Time frame: 48 hours post dose
Plasma DTG tlag
Time frame: 48 hours post dose
Number of subjects with adverse events
Time frame: 48 hours post dose
Toxicity grading of clinical laboratory tests
Time frame: 48 hours post dose
Change from baseline in vital signs (BP and HR)
Time frame: 48 hours post dose
Plasma ABC tlag
Time frame: 48 hours post dose
Plasma 3TC tlag
Time frame: 48 hours post dose
Plasma DTG tmax
Time frame: 48 hours post dose
Plasma ABC tmax
Time frame: 48 hours post dose
Plasma 3TC tmax
Time frame: 48 hours post dose
Plasma DTG t½
Time frame: 48 hours post dose
Plasma ABC t½
Time frame: 48 hours post dose
Plasma 3TC t½
Time frame: 48 hours post dose
Plasma DTG CL/F
Time frame: 48 hours post dose
Plasma ABC CL/F
Time frame: 48 hours post dose
Plasma 3TC CL/F
Time frame: 48 hours post dose
Plasma DTG Vz/F
Time frame: 48 hours post dose
Plasma ABC Vz/F
Time frame: 48 hours post dose
Plasma 3TC Vz/F
Time frame: 48 hours post dose
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 8 Aug 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.
GSK Clinical Trials study director
ViiV Healthcare
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 Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg, Dolutegravir 50 mg and abacavir 600 mg/lamivudine 300 mg in people with Healthy Subjects and Infection, Human Immunodeficiency Virus, run by ViiV Healthcare 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 8 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 8 Aug 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?
Plasma DTG AUC(0-infinity) (time frame: 48 hours post dose). The study lists 9 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 8 Aug 2011.