- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01332565
A Study to Investigate the Pharmacokinetics, Safety and Tolerability of GSK1349572 (Dolutegravir, DTG) in Healthy Japanese Subjects
June 23, 2011 updated by: ViiV Healthcare
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Cypress, California, United States, 90630
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Arm
All subjects will receive a 50 mg single dose of GSK1349572
|
50mg tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
for 72 hours
|
Plasma DTG pharmacokinetic parameters following single dose administration: maximum observed concentration (Cmax).
Time Frame: for 72 hours
|
for 72 hours
|
Plasma DTG pharmacokinetic parameters following single dose administration: concentration at 24h post-dose (C24).
Time Frame: for 72 hours
|
for 72 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma DTG pharmacokinetic parameters following single dose administration: time to maximum observed concentration (tmax)
Time Frame: for 72 hours
|
for 72 hours
|
Plasma DTG pharmacokinetic parameters following single dose administration: last quantifiable concentration (Ct).
Time Frame: for 72 hours
|
for 72 hours
|
Plasma DTG pharmacokinetic parameters following single dose administration: terminal phase half-life (t½)
Time Frame: for 72 hours
|
for 72 hours
|
Plasma DTG pharmacokinetic parameters following single dose administration: absorption lag time (tlag)
Time Frame: for 72 hours
|
for 72 hours
|
Plasma DTG pharmacokinetic parameters following single dose administration: apparent clearance (CL/F)
Time Frame: for 72 hours
|
for 72 hours
|
Plasma DTG pharmacokinetic parameters following single dose administration: mean residence time (MRT).
Time Frame: for 72 hours
|
for 72 hours
|
Plasma DTG pharmacokinetic parameters following single dose administration: apparent volume of distribution (Vz/F).
Time Frame: for 72 hours
|
for 72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
April 7, 2011
First Submitted That Met QC Criteria
April 7, 2011
First Posted (Estimate)
April 11, 2011
Study Record Updates
Last Update Posted (Estimate)
June 27, 2011
Last Update Submitted That Met QC Criteria
June 23, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- HIV Integrase Inhibitors
- Integrase Inhibitors
- Dolutegravir
Other Study ID Numbers
- 115381
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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