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Infection, Human Immunodeficiency VirusPhase 1NCT00711386

GSK706769 Repeat Dose Study

A Phase 1 study testing GSK706769 in people with Infection, Human Immunodeficiency Virus, run by GlaxoSmithKline at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To determine safety, tolerability and Pharmacokinetics of GSK706769 Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Infection, Human Immunodeficiency Virus
What is being tested?
GSK706769
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
16 May 2008to 12 Sep 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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
  • A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • Male or female between 18 and 50 years of age.
  • A female subject is eligible to participate if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any female who:
  • Is pre-menopausal with a documented bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries) or hysterectomy, or
  • Is post-menopausal defined as 12 months of spontaneous amenorrhea. A follicle stimulating hormone (FSH) level will be performed to confirm a post-menopausal status. For this study, FSH levels > 40 mlU/ml is confirmatory. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt, HRT should be discontinued for 2 weeks and then the subject rescreened, as HRT can suppress FSH.
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  • Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 14 days after the last dose of study medication.
  • Body weight ³ 50 kg for men and ³ 45 kg for women and BMI within the range 18.5-31.0 kg/m2 (inclusive).
  • 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.
  • 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 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. One drink is equivalent to (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.
  • 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).
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  • 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.
  • 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. This includes subjects with a history of known or suspected sulfa related hypersensitivity.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
  • Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
  • Lactating females.
  • Unwillingness or inability to follow the procedures outlined in the protocol. If heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
  • Has a history or regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
  • Consumption of grapefruit or grapefruit juice from 7 days prior to the first dose of study medication until the last pharmacokinetic sample.
  • 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.
  • 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.
  • History/evidence of symptomatic 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. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), direct bilirubin or creatinine values greater than the upper limit of normal. A single repeat is allowed for eligibility determination.
  • History of significant renal or hepatic diseases.
  • Exclusion Criteria for 24-Hour Screening Holter as per protocol.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GSK Investigational Site

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: A Double-Blind, Randomized, Placebo-Controlled, 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

Being tested
GSK706769, Placebo
Keywords
pharmacokinetics, CCR5, Healthy volunteers, GSK706769
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.

  • GSK706769Drug

    50mg, 100mg, 200mg, or 400mg

  • PlaceboOther

    Placebo

Study groups in NCT00711386
Study groupRoleWhat they receive
Cohort AExperimental50mg dose once daily for 7 days.
Receives: Drug: GSK706769; Other: Placebo
Cohort BExperimental100mg dose once daily for 8 days.
Receives: Drug: GSK706769; Other: Placebo
Cohort CExperimental200mg dose once daily for 8 days.
Receives: Drug: GSK706769; Other: Placebo
Cohort DExperimental400mg dose once daily for 7 days.
Receives: Drug: GSK706769; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. GSK706769 safety parameters: the number of adverse events

    Measured: From Day 1 to the follow up visit. Approximately 19 Days.

  2. GSK706769 safety parameters: clinical safety labs from predose values.

    Change from baseline values in clinical chemistry, hematology and urinalysis.

    Measured: From Day 1 to the follow up visit. Approximately 19 Days.

  3. GSK706769 safety parameters: vital signs (blood pressure and heart rate) from predose values

    Change from baseline values

    Measured: From Day 1 to the follow up visit. Approximately 19 days.

  4. GSK706769 safety parameters: electrocardiogram (ECG) intervals, ECG rhythm, and ECG axis from predose values.

    Change from baseline values

    Measured: From Day 1 to the follow up visit. Approximately 19 days.

  5. GSK706769 and GSK1996847 (metabolite) pharmacokinetic parameters following single dose administration on Day 1, when possible

    Area under the plasma concentration time curve (AUC(0-infinity), AUC(0-24)), maximum observed concentration (Cmax), time to maximum observed concentration (tmax), concentration at 24 hours post dose (C24), terminal half-life (t1/2), absorption lag time (tlag), apparent clearance (CL/F), metabolite-to-parent molar ratios for AUC(0-t) and Cmax; and following last repeat administration on Day 7 or 8: AUC(0-infinity), concentration at end of dosing interval (Ctau), Cmax, tlag, tmax, t1/2, and CL/F, metabolite-to-parent molar ratios for AUC(0-tau) and Cmax on Day 7 or 8.

    Measured: Day 7 or 8

Secondary outcomes (5)

  1. Plasma AUC(0-t), AUC(0-infinity), and CL/F of midazolam, with and without GSK706769 co-administration

    Measured: Day -1 and Day 8

  2. Plasma AUC(0-t) and Cmax of GSK706769 and GSK1996847

    Measured: on Day 7 (fasted) and Day 8 (fed).

  3. GSK706769 and GSK1996847 Day 7 AUC(0-t), Cmax, and Ct compared to Day 1 AUC(0-24), Cmax, and C24, respectively, to estimate accumulation ratios (R) for AUC, Cmax, and Ct.

    Measured: Day 1 and Day 7

  4. Pre-morning dose concentrations (Ct) on Day 3 through 7 to assess the achievement of steady state of GSK706769 and GSK1996847 following repeat administration.

    Measured: Day 3 through 7

  5. Day 7 AUC(0-t), Cmax and Ct of GSK706769 and GSK1996847 at different doses for the assessment of dose proportionality.

    Measured: Day -1 and Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2008 (estimated)
  2. Study start16 May 2008
  3. Primary completion12 Sep 2008
  4. Study completion12 Sep 2008

Resources

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
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00711386
Sponsor's protocol ID
CRR111382
Status last verified
Aug 2017
First submitted
3 Jul 2008
Last updated
3 Aug 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK706769 in people with Infection, Human Immunodeficiency Virus, 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 9 inclusion and 20 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 3 Aug 2017. 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?

GSK706769 safety parameters: the number of adverse events (time frame: From Day 1 to the follow up visit. Approximately 19 Days.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00711386.

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 3 Aug 2017.

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