Infection, Human Immunodeficiency VirusPhase 1NCT01332565
A Study to Investigate the Pharmacokinetics, Safety and Tolerability of GSK1349572 (Dolutegravir, DTG) in Healthy Japanese Subjects
A Phase 1 study testing GSK1349572 in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 1 site in United States.
Trial summary
This study is a Phase 1, open label, non-randomized, single dose study to determine pharmacokinetics, safety and tolerability of doultegravir (DTG) following 50 mg single oral administration in healthy Japanese subjects. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection, Human Immunodeficiency Virus
- What is being tested?
- GSK1349572
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jun 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is a healthy Japanese Japanese subjects who were born in Japan with 4 ethnic Japanese grandparents and must not have lived outside Japan for more than 5 years with being a Japanese passport holder. Healthy as judged by a responsible physician with no clinically significant abnormality identified on the medical or laboratory evaluation, including 12-lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
- The subject is greater than or equal to 20 and less than or equal to 55 years of age, inclusive.
- A female subject is eligible to participate if she is of: non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 mIU/mL and estradiol < 40 pg/mL (< 147 pmol/L) is confirmatory]. Child-bearing potential and agrees to use one of the contraception methods listed in the protocol for the time period between screening and dosing of study drugs to sufficiently minimize the risk of pregnancy at that point. Female subjects must also agree to use contraception throughout the study and until two weeks after the last dose of study medications.
- Body weight less than or equal to 50 kg (110 lbs.) for men and less than or equal to 45 kg (99 lbs.) for women and body mass index (BMI) between 18.5 to 28 kg/m2 inclusive.
- A signed and dated written informed consent is obtained from the subject prior to screening.
- The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned.
Who cannot join
- As a result of the medical interview, physical examination, or screening investigations, the Investigator considers the subject unfit for the study.
- The subject's systolic blood pressure is outside the range of 90-140 mmHg, or diastolic blood pressure is outside the range of 45-90 mmHg or heart rate is outside the range of 45-100 bpm for both male and female subjects. The subject's body temperature is > 37.5 degrees celcius.
- History/evidence of symptomatic or asymptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or congenital cardiac diseases or any clinically significant cardiac diseases.
- An episode of cardiac syncope within one year before screening period.
- History/evidence of clinically significant pulmonary diseases and hyper/hypo-thyroidism.
- Has a positive pre-study Hepatitis B surface antigen; positive hepatitis C (HCV) antibody or detectable HCV ribonucleic acid (RNA); or positive HIV-1 antibody result.
Show all 21Show fewer
- Has a history of regular alcohol consumption averaging > 7 drinks/week for women or >14 drinks/week for men (1 drink (12 g alcohol) = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits) within 6 months of the screening visit.
- Unwilling to abstain from alcohol for 48 hours prior to the start of dosing until collection of the final pharmacokinetic sample.
- Has a history of use of tobacco- or nicotine-containing products within 6 months of the screening visit.
- The subject has a positive pre-study drug and/or alcohol screen.
- Unwilling to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.
- The subject has received an investigational drug or participated in any other research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
- Participation in the study would result in donation of blood in excess of 500 mL within a 56 day period.
- History or presence of allergy or intolerance to the study drug or its components or drugs of its class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin induced thrombocytopenia should not be enrolled.
- Use of prescription or non-prescription drugs, including antacids, vitamins, herbal and dietary supplements (including St John's Wort and iron supplements) 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 sponsor the medication will not interfere with the study procedures or compromise subject safety.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, or serum creatinine values greater than the upper limit of normal. A single repeat is allowed for eligibility determination.
- 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 and pancreatitis should be excluded.
- History of significant renal or hepatic diseases.
- History of Gilbert's syndrome.
- Has an abnormal ECG as described in the protocol.
- Clinically significant anomaly in electrolytes in subjects with heart rate greater than or equal to 60/min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of GSK1349572 (Dolutegravir, DTG) in Healthy Japanese Subjects
This study is a Phase 1, open label, non-randomized, single dose study to determine pharmacokinetics, safety and tolerability of doultegravir (DTG) following 50 mg single oral administration in healthy Japanese subjects. A total of 10 healthy Japanese subjects will be enrolled in this study to receive a 50 mg single dose of DTG. Subjects will have a screening visit within 30 days prior to the administration of study drug, a treatment visit, and a follow-up visit 7-14 days after the administration of study drug.
Read the detailed description
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship
- Conditions
- Infection, Human Immunodeficiency Virus
- Being tested
- GSK1349572
- Keywords
- GSK1349572, pharmacokinetics, Japanese, HIV
- 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.
GSK1349572Drug
50mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | All subjects will receive a 50 mg single dose of GSK1349572 Receives: Drug: GSK1349572 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma DTG pharmacokinetic parameters following single dose administration: area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC(0-t)).
Measured: for 72 hours
Plasma DTG pharmacokinetic parameters following single dose administration: area under the plasma concentration-time curve from time zero to infinity (AUC(0-∞)).
Measured: for 72 hours
Plasma DTG pharmacokinetic parameters following single dose administration: maximum observed concentration (Cmax).
Measured: for 72 hours
Plasma DTG pharmacokinetic parameters following single dose administration: concentration at 24h post-dose (C24).
Measured: for 72 hours
Secondary outcomes (7)
Plasma DTG pharmacokinetic parameters following single dose administration: time to maximum observed concentration (tmax)
Measured: for 72 hours
Plasma DTG pharmacokinetic parameters following single dose administration: last quantifiable concentration (Ct).
Measured: for 72 hours
Plasma DTG pharmacokinetic parameters following single dose administration: terminal phase half-life (t½)
Measured: for 72 hours
Plasma DTG pharmacokinetic parameters following single dose administration: absorption lag time (tlag)
Measured: for 72 hours
Plasma DTG pharmacokinetic parameters following single dose administration: apparent clearance (CL/F)
Measured: for 72 hours
Plasma DTG pharmacokinetic parameters following single dose administration: mean residence time (MRT).
Measured: for 72 hours
Plasma DTG pharmacokinetic parameters following single dose administration: apparent volume of distribution (Vz/F).
Measured: for 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Human Immunodeficiency VirusStudies 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
- 10 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
- NCT01332565
- Sponsor's protocol ID
- 115381
- Status last verified
- Jun 2011
- First submitted
- 7 Apr 2011
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of GSK1349572 (Dolutegravir, DTG) in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT01332565
- Acronym / sponsor ID
- 115381
- Conditions
- Infection, Human Immunodeficiency Virus
- Keywords
- GSK1349572, pharmacokinetics, Japanese, HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Shionogi, GlaxoSmithKline
- Study start
- Apr 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Apr 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.
This study is a Phase 1, open label, non-randomized, single dose study to determine pharmacokinetics, safety and tolerability of doultegravir (DTG) following 50 mg single oral administration in healthy Japanese subjects. A total of 10 healthy Japanese subjects will be enrolled in this study to receive a 50 mg single dose of DTG. Subjects will have a screening visit within 30 days prior to the administration of study drug, a treatment visit, and a follow-up visit 7-14 days after the administration of study drug.
Detailed description
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: GSK1349572All subjects will receive a 50 mg single dose of GSK1349572 |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The subject is a healthy Japanese Japanese subjects who were born in Japan with 4 ethnic Japanese grandparents and must not have lived outside Japan for more than 5 years with being a Japanese passport holder. Healthy as judged by a responsible physician with no clinically significant abnormality identified on the medical or laboratory evaluation, including 12-lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
- The subject is greater than or equal to 20 and less than or equal to 55 years of age, inclusive.
- A female subject is eligible to participate if she is of: non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 mIU/mL and estradiol < 40 pg/mL (< 147 pmol/L) is confirmatory]. Child-bearing potential and agrees to use one of the contraception methods listed in the protocol for the time period between screening and dosing of study drugs to sufficiently minimize the risk of pregnancy at that point. Female subjects must also agree to use contraception throughout the study and until two weeks after the last dose of study medications.
- Body weight less than or equal to 50 kg (110 lbs.) for men and less than or equal to 45 kg (99 lbs.) for women and body mass index (BMI) between 18.5 to 28 kg/m2 inclusive.
- A signed and dated written informed consent is obtained from the subject prior to screening.
Key exclusion criteria (21 listed)
- As a result of the medical interview, physical examination, or screening investigations, the Investigator considers the subject unfit for the study.
- The subject's systolic blood pressure is outside the range of 90-140 mmHg, or diastolic blood pressure is outside the range of 45-90 mmHg or heart rate is outside the range of 45-100 bpm for both male and female subjects. The subject's body temperature is > 37.5 degrees celcius.
- History/evidence of symptomatic or asymptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or congenital cardiac diseases or any clinically significant cardiac diseases.
- An episode of cardiac syncope within one year before screening period.
- History/evidence of clinically significant pulmonary diseases and hyper/hypo-thyroidism.
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 |
|---|---|---|
| GSK134957250mg tablet | Drug | Single Arm |
Primary outcome
Plasma DTG pharmacokinetic parameters following single dose administration: area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC(0-t)).
Time frame: for 72 hours
Plasma DTG pharmacokinetic parameters following single dose administration: area under the plasma concentration-time curve from time zero to infinity (AUC(0-∞)).
Time frame: for 72 hours
Plasma DTG pharmacokinetic parameters following single dose administration: maximum observed concentration (Cmax).
Time frame: for 72 hours
Plasma DTG pharmacokinetic parameters following single dose administration: concentration at 24h post-dose (C24).
Time frame: for 72 hours
7 secondary outcomes
Plasma DTG pharmacokinetic parameters following single dose administration: time to maximum observed concentration (tmax)
Time frame: for 72 hours
Plasma DTG pharmacokinetic parameters following single dose administration: last quantifiable concentration (Ct).
Time frame: for 72 hours
Plasma DTG pharmacokinetic parameters following single dose administration: terminal phase half-life (t½)
Time frame: for 72 hours
Plasma DTG pharmacokinetic parameters following single dose administration: absorption lag time (tlag)
Time frame: for 72 hours
Plasma DTG pharmacokinetic parameters following single dose administration: apparent clearance (CL/F)
Time frame: for 72 hours
Plasma DTG pharmacokinetic parameters following single dose administration: mean residence time (MRT).
Time frame: for 72 hours
Plasma DTG pharmacokinetic parameters following single dose administration: apparent volume of distribution (Vz/F).
Time frame: for 72 hours
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 27 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.
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 GSK1349572 in people with 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 6 inclusion and 21 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 27 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?
Plasma DTG pharmacokinetic parameters following single dose administration: area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC(0-t)). (time frame: for 72 hours). The study lists 4 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 27 Jun 2011.