Infection, Human Immunodeficiency VirusPhase 1NCT01802918
Single Dose Escalation Study of GSK2838232 in Healthy Subjects
A Phase 1 study testing GSK2838232 and Ritonavir in people with Infection, Human Immunodeficiency Virus, run by GlaxoSmithKline at 1 site in United States.
Trial summary
GSK2838232 is a novel human immune virus (HIV) maturation inhibitor being developed for the treatment of chronic HIV infection. This study is the first administration of GSK2838232 in humans to establish the initial safety, tolerability, and pharmacokinetic profile following single doses of GSK2838232 and to evaluate… 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?
- GSK2838232 and Ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2013to 21 Nov 2013
- 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 and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinically significant 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 inclusive, at the time of signing the informed consent. 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 >40 milli international unit [MlU]/milliliter [mL] and estradiol <40 picogram [pg]/mL [<147 picomoles /liter] is confirmatory).
- Body weight >= 50 kilograms (kg) (110 pounds.) for men and >= 45 kg (99 pounds) for women and body mass index (BMI) within the range 18.5 to 31.0 kg/meter^2 (inclusive).
- A Creatinine clearance (CLcr) >80 mL/minute (min) as determined by Cockcroft-Gault equation. CLcr (mL/min) = (140 - age) x weight / (72 x serum creatinine [Scr]) (times 0.85 if female) where age is in years, weight is in kg, and Scr is in units of milligram (mg)/deciliter (dL).
- Male subjects with female partners of child-bearing potential must agree to use contraception method. This criterion must be followed from the time of the first dose of study medication until the follow up visit.
- Subject must be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin >= 1.5x Upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent).
- Screening or baseline cardiac troponin I greater than the 99 percent cutoff (>.045 nanogram [ng]/mL by the Dimension Vista cardiac troponin I [CTNI] assay).
- Screening BNP greater than the upper limit of normal
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
Show all 28Show fewer
- A positive test for Human Immuno Virus antibody.
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 grams of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine 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).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Unable to refrain from the 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 GlaxoSmithKline (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.
- 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 urine or serum human chorionic gonadotropin (hCG) test at screening or prior to dosing on Day 1.
- Lactating females.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Subjects who have asthma or a history of asthma
- A history of or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Unable to refrain from consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
- 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.
- Exclusion Criteria for 24-Hour Screening Holter are: any symptomatic arrhythmia (except isolated extra systoles), sustained cardiac arrhythmias (such as atrial fibrillation or flutter, supraventricular tachycardia (>=10 consecutive beats), 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, atrioventricular (AV) block [2nd degree or higher], Wolff-Parkinson-White [WPW]syndrome etc.), sinus Pauses > 3 seconds, 300 or more supraventricular ectopic beats in 24 hours, and 250 or more ventricular ectopic beats in 24 hours.
- Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination) are: Male subjects with Heart rate <45 and >100 beats per minute (bpm) and female subjects with heart rate <50 and >100 bpm, PR <120 and >220 milliseconds (msec), QRS duration <70 and >120 msec, QT interval corrected for heart rate (Fridericia's) >450 msec. (Note: A heart rate from 100 to 110 bpm can be rechecked by ECG or vitals within 30 minutes to verify eligibility).
- Evidence of previous myocardial infarction (Does not include ST segment changes associated with repolarization).
- Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block [2nd degree or higher], WPW syndrome).
- Sinus Pauses > 3 seconds. Any significant arrhythmia which, in the opinion of the principal investigator OR GSK medical monitor, will interfere with the safety for the individual subject.
- Non-sustained or sustained ventricular tachycardia (>=3 consecutive ventricular ectopic beats).
- Medical history of cardiac arrhythmias or cardiac disease or a family and personal history of long QT syndrome.
- Any clinically significant abnormal echocardiogram finding. Abnormal echocardiogram findings should be discussed with the Medical Monitor prior to enrolment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Single Dose Escalation First Time in Human Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK2838232 and to Evaluate the Effect of Food and Ritonavir on GSK2838232 in Healthy Subjects
GSK2838232 is a novel human immune virus (HIV) maturation inhibitor being developed for the treatment of chronic HIV infection. This study is the first administration of GSK2838232 in humans to establish the initial safety, tolerability, and pharmacokinetic profile following single doses of GSK2838232 and to evaluate the effect of food and ritonavir (RTV) on GSK2838232 in healthy subjects. There will be 2 cohorts in this study. In Cohort 1, approximately 8 healthy subjects will be enrolled (6 active and 2 placebo) at each dose visit. There will be four dosing sessions for each subject with subjects randomized to receive placebo in a random sequence. In Cohort 2, approximately 8 healthy subjects will be enrolled (6 active doses and 2 placebo doses at each dose visit). Cohort 2 will have four dosing sessions for each subject with subjects randomized to receive placebo in a random sequence.
- Conditions
- Infection, Human Immunodeficiency Virus
- Being tested
- GSK2838232, Placebo, Ritonavir
- Keywords
- single dose, HIV, maturation inhibitor, GSK2838232, FTIH, healthy subjects
- 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.
GSK2838232Drug
Bottled powder with 5, 10 and 20mg unit dose strength per single dose for re-constituted oral suspension given once daily
PlaceboDrug
Visually matching GSK2838232
RitonavirDrug
100mg tablets once daily for 12 days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Subject in this cohort will be randomized to one of the four following treatment sequences (1 treatment per visit): ABCD, BACD, BCAD, or BCDA. Where A=Placebo, B= GSK2838232 5mg, C=GSK2838232 10mg, and D=GSK2838232 20mg Receives: Drug: GSK2838232; Drug: Placebo |
| Cohort 2 | Experimental | Subject in this cohort will be randomized to one of the four following treatment sequences (1 treatment per visit): EGHJ, FEHJ, FGIJ, or FGHK. Where E=Placebo, F= GSK2838232 50mg, G= GSK2838232 100mg, H= GSK2838232 50mg + food, I= Placebo + food, J= GSK2838232 10mg + RTV, K= placebo + RTV. Receives: Drug: GSK2838232; Drug: Placebo; Drug: Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events (AEs) as a measure of safety and tolerability in cohort 1
AEs will be collected from the start of Study Treatment and until 5 days post last-dose (at follow up).
Measured: Up to 16 weeks
Number of subjects with AEs as a measure of safety and tolerability in cohort 2.
AEs will be collected from the start of Study Treatment and until 5 days post last-dose (at follow up).
Measured: Up to 12 weeks
Absolute values and changes over time of hematology as a measure of safety and tolerability in cohort 1.
Measured: Up to 16 weeks
Absolute values and changes over time of hematology as a measure of safety and tolerability in cohort 2
Measured: Up to 12 weeks
Absolute values and changes over time of clinical chemistry as a measure of safety and tolerability in cohort 1.
Measured: Up to 16 weeks
Absolute values and changes over time of clinical chemistry as a measure of safety and tolerability in cohort 2.
Measured: Up to 12 weeks
Absolute values and changes over time of urinalysis as a measure of safety and tolerability in cohort 1.
Measured: Up to 16 weeks
Absolute values and changes over time of urinalysis as a measure of safety and tolerability in cohort 2
Measured: Up to 12 weeks
Absolute values and changes over time of vital signs as a measure of safety and tolerability in cohort 1
Vital signs include blood pressure, temperature and heart rate measurement
Measured: Up to 16 weeks.
Absolute values and changes over time of vital signs as a measure of safety and tolerability in cohort 2.
Vital signs include blood pressure, temperature and heart rate measurement
Measured: Up to 12 weeks
Absolute values and changes over time of ECG intervals and ECG rhythm as a measure of safety and tolerability in cohort 1.
Measured: Up to 16 weeks.
Absolute values and changes over time of ECG intervals and ECG rhythm as a measure of safety and tolerability in cohort 2.
Measured: Up to 12 weeks
Real time collection and review of heart rhythm using telemetry as a measure of safety and tolerability in cohort 1.
Measured: Up to 16 weeks.
Real time collection and review of heart rhythm using telemetry as a measure of safety and tolerability in cohort 2.
Measured: Up to 12 weeks
Composite of pharmacokinetics (PK) parameters following single dose administration of GSK2838232 in cohort 1
PK parameters include: area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC [0-infinity]), area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC [0-t]), maximum observed concentration (Cmax), time to maximum observed concentration (Tmax), observed concentration at 24hour post-dose (C24), last observed quantifiable concentration (Ct), lag time before observation of drug concentrations in sampled matrix (tlag), terminal half-life (t1/2), and apparent oral clearance (CL/F).
Measured: PK samples will be collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours post dose in each dosing session and at follow up visit.
Composite of pharmacokinetics parameters following single dose administration of GSK2838232 in cohort 2.
PK parameters include: AUC (0-infinity), AUC (0-t), Cmax, Tmax, C24, Ct, tlag, t1/2 and CL/F.
Measured: PK samples will be collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours post dose in each dosing session and at follow up visit.
Secondary outcomes (2)
Composite of pharmacokinetics parameters following single dose administration of GSK2838232 with and without food in cohort 2.
PK parameters include: AUC (0-infinity), AUC (0-t), Cmax, Tmax, C24 and t1/2. Food will be normal fat meal.
Measured: PK samples will be collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours post dose in each dosing session and at follow up visit.
Composite of pharmacokinetics parameters following single dose administration of GSK2838232 with co-administration of ritonavir in cohort 2.
PK parameters include: AUC (0-infinity), AUC (0-t), Cmax, Tmax, C24 and t1/2.
Measured: PK samples will be collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours post dose in each dosing session and at follow up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study start18 Feb 2013
- Primary completion21 Nov 2013
- Study completion21 Nov 2013
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 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802918
- Sponsor's protocol ID
- 116787
- Status last verified
- May 2017
- First submitted
- 14 Feb 2013
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Single Dose Escalation First Time in Human Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK2838232 and to Evaluate the Effect of Food and Ritonavir on GSK2838232 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01802918
- Acronym / sponsor ID
- 116787
- Conditions
- Infection, Human Immunodeficiency Virus
- Keywords
- single dose, HIV, maturation inhibitor, GSK2838232, FTIH, healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2013 (actual)
- Primary completion
- 21 Nov 2013 (actual)
- Study completion
- 21 Nov 2013 (actual)
- First posted
- 4 Mar 2013 (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.
GSK2838232 is a novel human immune virus (HIV) maturation inhibitor being developed for the treatment of chronic HIV infection. This study is the first administration of GSK2838232 in humans to establish the initial safety, tolerability, and pharmacokinetic profile following single doses of GSK2838232 and to evaluate the effect of food and ritonavir (RTV) on GSK2838232 in healthy subjects. There will be 2 cohorts in this study. In Cohort 1, approximately 8 healthy subjects will be enrolled (6 active and 2 placebo) at each dose visit. There will be four dosing sessions for each subject with subjects randomized to receive placebo in a random sequence. In Cohort 2, approximately 8 healthy subjects will be enrolled (6 active doses and 2 placebo doses at each dose visit). Cohort 2 will have four dosing sessions for each subject with subjects randomized to receive placebo in a random sequence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: GSK2838232, Drug: PlaceboSubject in this cohort will be randomized to one of the four following treatment sequences (1 treatment per visit): ABCD, BACD, BCAD, or BCDA. Where A=Placebo, B= GSK2838232 5mg, C=GSK2838232 10mg, and D=GSK2838232 20mg |
| Cohort 2 | Experimental | Drug: GSK2838232, Drug: Placebo, Drug: RitonavirSubject in this cohort will be randomized to one of the four following treatment sequences (1 treatment per visit): EGHJ, FEHJ, FGIJ, or FGHK. Where E=Placebo, F= GSK2838232 50mg, G= GSK2838232 100mg, H= GSK2838232 50mg + food, I= Placebo + food, J= GSK2838232 10mg + RTV, K= placebo + RTV. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinically significant 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 inclusive, at the time of signing the informed consent. 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 >40 milli international unit [MlU]/milliliter [mL] and estradiol <40 picogram [pg]/mL [<147 picomoles /liter] is confirmatory).
- Body weight >= 50 kilograms (kg) (110 pounds.) for men and >= 45 kg (99 pounds) for women and body mass index (BMI) within the range 18.5 to 31.0 kg/meter^2 (inclusive).
- A Creatinine clearance (CLcr) >80 mL/minute (min) as determined by Cockcroft-Gault equation. CLcr (mL/min) = (140 - age) x weight / (72 x serum creatinine [Scr]) (times 0.85 if female) where age is in years, weight is in kg, and Scr is in units of milligram (mg)/deciliter (dL).
- Male subjects with female partners of child-bearing potential must agree to use contraception method. This criterion must be followed from the time of the first dose of study medication until the follow up visit.
Key exclusion criteria (28 listed)
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin >= 1.5x Upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent).
- Screening or baseline cardiac troponin I greater than the 99 percent cutoff (>.045 nanogram [ng]/mL by the Dimension Vista cardiac troponin I [CTNI] assay).
- Screening BNP greater than the upper limit of normal
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
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 |
|---|---|---|
| GSK2838232Bottled powder with 5, 10 and 20mg unit dose strength per single dose for re-constituted oral suspension given once daily | Drug | Cohort 1, Cohort 2 |
| PlaceboVisually matching GSK2838232 | Drug | Cohort 1, Cohort 2 |
| Ritonavir100mg tablets once daily for 12 days | Drug | Cohort 2 |
Primary outcome
Number of subjects with adverse events (AEs) as a measure of safety and tolerability in cohort 1
Time frame: Up to 16 weeks
AEs will be collected from the start of Study Treatment and until 5 days post last-dose (at follow up).
Number of subjects with AEs as a measure of safety and tolerability in cohort 2.
Time frame: Up to 12 weeks
AEs will be collected from the start of Study Treatment and until 5 days post last-dose (at follow up).
Absolute values and changes over time of hematology as a measure of safety and tolerability in cohort 1.
Time frame: Up to 16 weeks
Absolute values and changes over time of hematology as a measure of safety and tolerability in cohort 2
Time frame: Up to 12 weeks
Absolute values and changes over time of clinical chemistry as a measure of safety and tolerability in cohort 1.
Time frame: Up to 16 weeks
Absolute values and changes over time of clinical chemistry as a measure of safety and tolerability in cohort 2.
Time frame: Up to 12 weeks
Absolute values and changes over time of urinalysis as a measure of safety and tolerability in cohort 1.
Time frame: Up to 16 weeks
Absolute values and changes over time of urinalysis as a measure of safety and tolerability in cohort 2
Time frame: Up to 12 weeks
Absolute values and changes over time of vital signs as a measure of safety and tolerability in cohort 1
Time frame: Up to 16 weeks.
Vital signs include blood pressure, temperature and heart rate measurement
Absolute values and changes over time of vital signs as a measure of safety and tolerability in cohort 2.
Time frame: Up to 12 weeks
Vital signs include blood pressure, temperature and heart rate measurement
Absolute values and changes over time of ECG intervals and ECG rhythm as a measure of safety and tolerability in cohort 1.
Time frame: Up to 16 weeks.
Absolute values and changes over time of ECG intervals and ECG rhythm as a measure of safety and tolerability in cohort 2.
Time frame: Up to 12 weeks
Real time collection and review of heart rhythm using telemetry as a measure of safety and tolerability in cohort 1.
Time frame: Up to 16 weeks.
Real time collection and review of heart rhythm using telemetry as a measure of safety and tolerability in cohort 2.
Time frame: Up to 12 weeks
Composite of pharmacokinetics (PK) parameters following single dose administration of GSK2838232 in cohort 1
Time frame: PK samples will be collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours post dose in each dosing session and at follow up visit.
PK parameters include: area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC [0-infinity]), area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC [0-t]), maximum observed concentration (Cmax), time to maximum observed concentration (Tmax), observed concentration at 24hour post-dose (C24), last observed quantifiable concentration (Ct), lag time before observation of drug concentrations in sampled matrix (tlag), terminal half-life (t1/2), and apparent oral clearance (CL/F).
Composite of pharmacokinetics parameters following single dose administration of GSK2838232 in cohort 2.
Time frame: PK samples will be collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours post dose in each dosing session and at follow up visit.
PK parameters include: AUC (0-infinity), AUC (0-t), Cmax, Tmax, C24, Ct, tlag, t1/2 and CL/F.
2 secondary outcomes
Composite of pharmacokinetics parameters following single dose administration of GSK2838232 with and without food in cohort 2.
Time frame: PK samples will be collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours post dose in each dosing session and at follow up visit.
Composite of pharmacokinetics parameters following single dose administration of GSK2838232 with co-administration of ritonavir in cohort 2.
Time frame: PK samples will be collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours post dose in each dosing session and at follow up visit.
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 9 May 2017.
- Results for study 116787 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Related trials for Infection, Human Immunodeficiency Virus
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
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
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 GSK2838232 and Ritonavir 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 6 inclusion and 28 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 9 May 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?
Number of subjects with adverse events (AEs) as a measure of safety and tolerability in cohort 1 (time frame: Up to 16 weeks). The study lists 16 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 9 May 2017.