Healthy SubjectsPhase 1NCT00539201
GSK706769 A First Time in Human Study For Males and Females
A Phase 1 study testing GSK706769 in people with Healthy Subjects, run by GlaxoSmithKline at 1 site in United States.
Trial summary
To determine safety, tolerability and pharmacokinetics of GSK706769 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- GSK706769
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Feb 2008
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is healthy. 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 ≥18 and ≤65 years of age.
- The subject is male or female.
- A female is eligible to enter and participate in this study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who:
- Has had a hysterectomy or
- Has had a bilateral oophorectomy (removal of the ovaries) or
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- Has had a bilateral tubal ligation or
- Is post-menopausal (a demonstration of total cessation of menses for ≥ 1 year from the date of screening visit). An FSH level will be performed to confirm a post-menopausal state. For this study FSH levels ≥ 40mIU/mL are consistent with menopause. If a subject is on estrogen replacement and menopausal status is questionable, estrogen replacement should be discontinued for 2 weeks and then the subject rescreened, as estrogen replacement can suppress FSH.
- A male is eligible to enter and participate in the study if he is surgically sterile OR if he either agrees to abstain from sexual intercourse with a female partner or agrees to use a condom/spermicide, in addition to having his female partner use another form of contraception, such as an IUD, occlusive cap (diaphragm or cervical/vault cap) with spermicide, oral contraceptives, injectable progesterone, subdermal implants, female condom, contraceptive patch, or contraceptive vaginal ring, or has had a tubal ligation or hysterectomy. These criteria must be followed from the time of the first dose of study medication until 84 days after the last dose of study medication.
- Body weight ≥ 50 kg (110 lbs.) for men and ≥ 45 kg (99 lbs.) for women and body mass index (BMI) between 18.5-29.9 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 90-140mmHg, 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 45-100bpm for male subjects.
- History/evidence of symptomatic or asymptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or any clinically significant cardiac disease.
- History/evidence of clinically significant pulmonary disease.
- Has a positive pre-study Hepatitis B surface antigen; positive HCV antibody; 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.
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- Unwilling to abstain from alcohol for 72 hours prior to the start of dosing until collection of the final pharmacokinetic sample during each treatment period.
- Has a history of regular use of tobacco- or nicotine-containing products within 3 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 drugs or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation. This includes subjects with a history of known or suspected sulfa related hypersensitivity. 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. Note: "Study" or "investigational" drugs includes GSK706769, placebo, lopinavir, ritonavir, midazolam, and flumazenil.
- 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 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 or hemoglobin outside the normal range at screening. 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 should be excluded. Subjects with, or having a history of, gastritis or peptic ulcer disease should be excluded.
- History of significant renal or hepatic diseases.
- History of Gilbert's syndrome.
- Subjects with a positive immunoassay fecal occult blood test prior to the start of dosing study drugs (repeat dose cohorts only)
- 24-Hour Screening Holter:
- Any symptomatic arrhythmia (except isolated extra systoles).
- Sustained cardiac arrhythmias (such as atrial fibrillation or flutter, SVT, complete heart block).
- Non-sustained or sustained ventricular tachycardia (defined as ≥ 3 consecutive ventricular ectopic beats).
- Any conduction abnormality (including but not specific to left or right incomplete or complete bundle branch block, AV block [2nd degree or higher], WPW syndrome etc.).
- Sinus Pauses >2.5 seconds.
- 300 or more supraventricular ectopic beats in 24 hours.
- 250 or more ventricular ectopic beats in 24 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Parallel, Randomized, Placebo-Controlled, Single and Repeat Dose Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GSK706769 in Healthy Male and Female Subjects
To determine safety, tolerability and pharmacokinetics of GSK706769
- Conditions
- Healthy Subjects
- Being tested
- GSK706769
- Keywords
- GSK706769,, CCR5 inhibitor,, HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK706769Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood levels of drug
Measured: over 48 hours or 14 days.
Laboratory test results
Measured: over 48 hours or 14 days
Vital signs
Measured: over 48 hours or 14 days
Secondary outcomes (12)
Effect of food on blood levels of drug
Measured: over 48 hours
Effect of Kaletra on blood levels of drug
Measured: over 48 hours
Effect of midazolam on drug levels
Measured: over 12 hours
Plasma GSK706769 PK parameters, AUC(0-∞) or AUC(0-t), Cmax, tmax and tlag following single dose administration of a given dose of GSK706769 with and without high fat/calorie meal.
Plasma GSK706769 PK parameters, AUC(0-∞), AUC(0-t), Cmax, C12, and t1/2 following a single dose of GSK706769 with and without a single dose of LPV/RTV 400/100mg.
Safety parameters during LPV/RTV 400mg/100mg or high fat/calorie meal
Plasma AUC(0-∞) and CL/F of midazolam, a surrogate estimate of CYP3A enzyme activity, with and without GSK706769 co-administration.
Plasma GSK706769 PK parameters, AUC(0-∞) or AUC(0-t), Cmax, tmax and tlag, following single oral dose administered as tablet and solution.
Percentage and rate of change in CCR5 RO.
Day 14 GSK706769 AUC(0-τ) compared to Day 1 AUC(0-12) (if BID dosing) or Day 1 AUC(0-24) (if QD dosing) to estimate accumulation ratio (R) and GSK706769 AUC(0-τ) on Day 14 compared to AUC(0-∞) on Day 1 to evaluate time invariance
Pre-morning dose concentrations (Cτ) on Day 2 through 14 to assess the achievement of steady state of GSK706769 following repeat administration.
GSK706769 PK parameters: AUC(0-∞), AUC(0-t), and Cmax following single dose administration and AUC(0-τ), Cτ, and Cmax following repeat administration at different doses for the assessment of dose proportionality.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionFeb 2008
- Study completionFeb 2008
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 GlaxoSmithKlineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539201
- Sponsor's protocol ID
- CRR110198
- Status last verified
- Oct 2010
- First submitted
- 2 Oct 2007
- Last updated
- 19 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Parallel, Randomized, Placebo-Controlled, Single and Repeat Dose Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GSK706769 in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT00539201
- Acronym / sponsor ID
- CRR110198
- Conditions
- Healthy Subjects
- Keywords
- GSK706769,, CCR5 inhibitor,, HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 34 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 4 Oct 2007 (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.
To determine safety, tolerability and pharmacokinetics of GSK706769
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- The subject is healthy. 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 ≥18 and ≤65 years of age.
- The subject is male or female.
- A female is eligible to enter and participate in this study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who:
- A male is eligible to enter and participate in the study if he is surgically sterile OR if he either agrees to abstain from sexual intercourse with a female partner or agrees to use a condom/spermicide, in addition to having his female partner use another form of contraception, such as an IUD, occlusive cap (diaphragm or cervical/vault cap) with spermicide, oral contraceptives, injectable progesterone, subdermal implants, female condom, contraceptive patch, or contraceptive vaginal ring, or has had a tubal ligation or hysterectomy. These criteria must be followed from the time of the first dose of study medication until 84 days after the last dose of study medication.
Key exclusion criteria (27 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 90-140mmHg, 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 45-100bpm for male subjects.
- History/evidence of symptomatic or asymptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or any clinically significant cardiac disease.
- History/evidence of clinically significant pulmonary disease.
- Has a positive pre-study Hepatitis B surface antigen; positive HCV antibody; or positive HIV-1 antibody result.
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 |
|---|---|---|
| GSK706769 | Drug | – |
Primary outcome
Blood levels of drug
Time frame: over 48 hours or 14 days.
Laboratory test results
Time frame: over 48 hours or 14 days
Vital signs
Time frame: over 48 hours or 14 days
12 secondary outcomes
Effect of food on blood levels of drug
Time frame: over 48 hours
Effect of Kaletra on blood levels of drug
Time frame: over 48 hours
Effect of midazolam on drug levels
Time frame: over 12 hours
Plasma GSK706769 PK parameters, AUC(0-∞) or AUC(0-t), Cmax, tmax and tlag following single dose administration of a given dose of GSK706769 with and without high fat/calorie meal.
Plasma GSK706769 PK parameters, AUC(0-∞), AUC(0-t), Cmax, C12, and t1/2 following a single dose of GSK706769 with and without a single dose of LPV/RTV 400/100mg.
Safety parameters during LPV/RTV 400mg/100mg or high fat/calorie meal
Plasma AUC(0-∞) and CL/F of midazolam, a surrogate estimate of CYP3A enzyme activity, with and without GSK706769 co-administration.
Plasma GSK706769 PK parameters, AUC(0-∞) or AUC(0-t), Cmax, tmax and tlag, following single oral dose administered as tablet and solution.
Percentage and rate of change in CCR5 RO.
Day 14 GSK706769 AUC(0-τ) compared to Day 1 AUC(0-12) (if BID dosing) or Day 1 AUC(0-24) (if QD dosing) to estimate accumulation ratio (R) and GSK706769 AUC(0-τ) on Day 14 compared to AUC(0-∞) on Day 1 to evaluate time invariance
Pre-morning dose concentrations (Cτ) on Day 2 through 14 to assess the achievement of steady state of GSK706769 following repeat administration.
GSK706769 PK parameters: AUC(0-∞), AUC(0-t), and Cmax following single dose administration and AUC(0-τ), Cτ, and Cmax following repeat administration at different doses for the assessment of dose proportionality.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2010.
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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, MD study director
GlaxoSmithKline
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 GSK706769 in people with Healthy Subjects, run by GlaxoSmithKline 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 12 inclusion and 27 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: stopped early, as of the sponsor's last update on 19 Oct 2010. 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 was stopped early. Results are not available in the source record.
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?
Blood levels of drug (time frame: over 48 hours or 14 days.). 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 19 Oct 2010.