Infection, Human Immunodeficiency VirusPhase 1NCT01273103
A Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK2248761 Administered as an Oral Suspension to Healthy Adult Subjects
A Phase 1 study testing 200mg [14C]- GSK2248761 in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 1 site in United States.
Trial summary
This study is a Phase I, open-label, single dose, mass balance study in a cohort of 6 healthy adult male subjects. The study will consist of: Screening evaluations, a treatment phase, and follow-up evaluations. Read more about this study
- Who is it for?
- Ages 30 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infection, Human Immunodeficiency Virus
- What is being tested?
- 200mg [14C]- GSK2248761
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Feb 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 30 to 55 years
- Men only
- 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.
- Male subjects between 30 and 55 years of age.
- Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until 84 days after the dose of study medication. Male subjects also must refrain from the donation of sperm during this time as well.
- Body weight greater than or equal to 50 kg and body mass index (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.
- Available to complete the study (minimum of 7 and a maximum of 11 night's confinement in the clinical research unit).
- A history of regular bowel movements (averaging one or more bowel movements per day).
- AST, ALT, alkaline phosphatase and bilirubin greater than or equal to 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). A single repeat is allowed for eligibility determination.
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 antacids, 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
Show all 17Show fewer
- Has a history or regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
- Subjects who have received a total body radiation dose of greater than 5.0 mSv (upper limit of WHO category II) or exposure to significant radiation (e.g. serial x-ray or CT scans, barium meal etc) in the 12 months prior to this study. Any previous radiolabeled study drug must have been received more than 6 months prior to check-in. Also the total exposure from this current study and any previous studies must be within the recommended levels considered safe of 5 Rems whole body annual exposure, as per United States (US) Code of Federal Regulations (CFR) 21 CFR 361.1.
- Any condition that could interfere with the accurate assessment and recovery of radiocarbon [14C].
- 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 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.
- 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 45-100 bpm. A single repeat is allowed to determine eligibility.
- An abnormal ECG as specified in the protocol (a single repeat is allowed for eligibility determination).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Single Dose, Mass Balance Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK2248761 200 mg, Administered as an Oral Suspension to Healthy Adult Subjects
This study is a Phase I, open-label, single dose, mass balance study in a cohort of 6 healthy adult male subjects. The study will consist of: Screening evaluations, a treatment phase, and follow-up evaluations. In the treatment phase, after an overnight fast of at least 10 hours, each subject will receive a single oral suspension dose of GSK2248761 200mg containing [14C] - GSK2248761. Following dosing, serial whole blood, plasma, urine, and fecal samples will be collected. Subjects will be required to remain in the unit until the radiocarbon excreted falls to less than or equal to 1% of the administered dose for two consecutive 24-hour collections in both urine and feces, whichever occurs first. Safety will be assessed by vital signs, 12-lead electrocardiogram (ECG), clinical laboratory tests, AE monitoring, and physical examinations as indicated.
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
- 200mg [14C]- GSK2248761
- 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.
200mg [14C]- GSK2248761Drug
single oral suspension dose of [14C]- GSK2248761 200 mg
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | [14C]- GSK2248761 200 mg Receives: Drug: 200mg [14C]- GSK2248761 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent recovery of total radiocarbon in urine and feces
Measured: up to 10 days
Area under the concentration-time curve from time zero to last time of quantifiable concentration within a subject (AUC (0-t)) of total drug-related material (radiocarbon) in blood and plasma
Measured: up to 10 days
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC (0-infinity)) of total drug-related material (radiocarbon) in blood and plasma
Measured: up to 10 days
Percentage of AUC(0-infinity) obtained by extrapolation (%AUCex) of total drug-related material (radiocarbon) in blood and plasma.
Measured: up to 10 days
Minimum observed concentration (Cmax) of total drug-related material (radiocarbon) in blood and plasma
Measured: up to 10 days
Time occurence of Cmax (tmax) of total drug-related material (radiocarbon) in blood and plasma
Measured: up to 10 days
Terminal phase rate constant (lambda z) of total drug-related material (radiocarbon) in blood and plasma
Measured: up to 10 days
Lag time before observation of drug concentrations in sampled matrix (tlag) of total drug-related material (radiocarbon) in blood and plasma
Measured: up to 10 days
Terminal phase half life (t1/2) of total drug-related material (radiocarbon) in blood and plasma
Measured: up to 10 days
AUC (0-t) of GSK2248761 in plasma
Measured: up to 10 days
AUC (0-infinity) of GSK2248761 in plasma
Measured: up to 10 days
%AUCex of GSK2248761 in plasma
Measured: up to 10 days
Cmax of GSK2248761 in plasma
Measured: up to 10 days
tmax of GSK2248761 in plasma
Measured: up to 10 days
Lambda z of GSK2248761 in plasma
Measured: up to 10 days
tlag of GSK2248761 in plasma
Measured: up to 10 days
Apparent clearance following oral dosing (CL/F) of GSK2248761 in plasma
Measured: up to 10 days
Apparent volume of distribution after oral administration (Vz/F) of GSK2248761 in plasma
Measured: up to 10 days
t1/2 of GSK2248761 in plasma
Measured: up to 10 days
Secondary outcomes (6)
Safety and tolerability parameters including number of adverse events (AEs)
Measured: up to 25 days
Safety and tolerability parameters including change from baseline for vital signs (blood pressure and heart rate)
Measured: up to 25 days
Safety and tolerability parameters including change from baseline for electrocardiogram assessments (ECGs)
Measured: up to 25 days
Safety and tolerability parameters including change from baseline for clinical laboratory assessments
Measured: up to 25 days
Blood:plasma ratio of total drug-related material (radioactivity)
Measured: up to 10 days
Percent of total radiocarbon associated with red blood cells
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2011
- Study completionFeb 2011 (estimated)
Why it stopped: GSK2248761 development program is on clinical hold.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273103
- Sponsor's protocol ID
- 113393
- Status last verified
- May 2014
- First submitted
- 6 Jan 2011
- Last updated
- 19 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Dose, Mass Balance Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK2248761 200 mg, Administered as an Oral Suspension to Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01273103
- Acronym / sponsor ID
- 113393
- Conditions
- Infection, Human Immunodeficiency Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: GSK2248761 development program is on clinical hold.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Jan 2011
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (estimated)
- First posted
- 10 Jan 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 I, open-label, single dose, mass balance study in a cohort of 6 healthy adult male subjects. The study will consist of: Screening evaluations, a treatment phase, and follow-up evaluations. In the treatment phase, after an overnight fast of at least 10 hours, each subject will receive a single oral suspension dose of GSK2248761 200mg containing [14C] - GSK2248761. Following dosing, serial whole blood, plasma, urine, and fecal samples will be collected. Subjects will be required to remain in the unit until the radiocarbon excreted falls to less than or equal to 1% of the administered dose for two consecutive 24-hour collections in both urine and feces, whichever occurs first. Safety will be assessed by vital signs, 12-lead electrocardiogram (ECG), clinical laboratory tests, AE monitoring, and physical examinations as indicated.
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 |
|---|---|---|
| Treatment | Experimental | Drug: 200mg [14C]- GSK2248761[14C]- GSK2248761 200 mg |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Male subjects between 30 and 55 years of age.
- Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until 84 days after the dose of study medication. Male subjects also must refrain from the donation of sperm during this time as well.
- Body weight greater than or equal to 50 kg and body mass index (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.
Key exclusion criteria (17 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 antacids, 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 |
|---|---|---|
| 200mg [14C]- GSK2248761single oral suspension dose of [14C]- GSK2248761 200 mg | Drug | Treatment |
Primary outcome
Percent recovery of total radiocarbon in urine and feces
Time frame: up to 10 days
Area under the concentration-time curve from time zero to last time of quantifiable concentration within a subject (AUC (0-t)) of total drug-related material (radiocarbon) in blood and plasma
Time frame: up to 10 days
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC (0-infinity)) of total drug-related material (radiocarbon) in blood and plasma
Time frame: up to 10 days
Percentage of AUC(0-infinity) obtained by extrapolation (%AUCex) of total drug-related material (radiocarbon) in blood and plasma.
Time frame: up to 10 days
Minimum observed concentration (Cmax) of total drug-related material (radiocarbon) in blood and plasma
Time frame: up to 10 days
Time occurence of Cmax (tmax) of total drug-related material (radiocarbon) in blood and plasma
Time frame: up to 10 days
Terminal phase rate constant (lambda z) of total drug-related material (radiocarbon) in blood and plasma
Time frame: up to 10 days
Lag time before observation of drug concentrations in sampled matrix (tlag) of total drug-related material (radiocarbon) in blood and plasma
Time frame: up to 10 days
Terminal phase half life (t1/2) of total drug-related material (radiocarbon) in blood and plasma
Time frame: up to 10 days
AUC (0-t) of GSK2248761 in plasma
Time frame: up to 10 days
AUC (0-infinity) of GSK2248761 in plasma
Time frame: up to 10 days
%AUCex of GSK2248761 in plasma
Time frame: up to 10 days
Cmax of GSK2248761 in plasma
Time frame: up to 10 days
tmax of GSK2248761 in plasma
Time frame: up to 10 days
Lambda z of GSK2248761 in plasma
Time frame: up to 10 days
tlag of GSK2248761 in plasma
Time frame: up to 10 days
Apparent clearance following oral dosing (CL/F) of GSK2248761 in plasma
Time frame: up to 10 days
Apparent volume of distribution after oral administration (Vz/F) of GSK2248761 in plasma
Time frame: up to 10 days
t1/2 of GSK2248761 in plasma
Time frame: up to 10 days
6 secondary outcomes
Safety and tolerability parameters including number of adverse events (AEs)
Time frame: up to 25 days
Safety and tolerability parameters including change from baseline for vital signs (blood pressure and heart rate)
Time frame: up to 25 days
Safety and tolerability parameters including change from baseline for electrocardiogram assessments (ECGs)
Time frame: up to 25 days
Safety and tolerability parameters including change from baseline for clinical laboratory assessments
Time frame: up to 25 days
Blood:plasma ratio of total drug-related material (radioactivity)
Time frame: up to 10 days
Percent of total radiocarbon associated with red blood cells
Time frame: up to 10 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
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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 200mg [14C]- GSK2248761 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 8 inclusion and 17 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: withdrawn, as of the sponsor's last update on 19 May 2014. 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 withdrawn before enrolling participants, so there are no results.
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?
Percent recovery of total radiocarbon in urine and feces (time frame: up to 10 days). The study lists 19 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 May 2014.