Infection, Human Immunodeficiency VirusPhase 1NCT02795754

Single and Repeated Dose Escalation Study of GSK2838232

A Phase 1 study testing GSK2838232 PIB, GSK2838232 IR1 and GSK2838232 IR2 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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Infection, Human Immunodeficiency Virus
What is being tested?: GSK2838232 PIB, GSK2838232 IR1 and GSK2838232 IR2
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 62 participants
Where: 1 siteUnited States
Study dates: Mar 2016to Dec 2016
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

Age: Between 18 and 55 years of age inclusive, at the time of signing the informed consent.
Healthy as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, and outside the reference range for the population being studied, may be included only if the Investigator in consultation with the Medical Monitor, if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
A creatinine clearance (CLcr) >80milliliter/minute (mL/min) as determined by Cockcroft-Gault equation CLcr (mL/min) = (140 - age) * weight (Wt) / (72 * serum creatinine [Scr]) (times 0.85 if female) where age is in years, Wt is in kilogram (kg), and Scr is in units of milligram / decilitre (mg/dL);.
Body weight >= 50.0 kg (110 pounds [lbs.]) for men and >= 45.0kg (99lbs) for women and body mass index (BMI)
Male or females of non-reproductive potential:

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A female subject is eligible to participate if she is not pregnant [as confirmed by a negative serum human chorionic gonadotrophin (hCG) test], not lactating, and of non-reproductive potential which is defined as:
Pre-menopausal females with one of the following: Documented tubal ligation; Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion ; Hysterectomy; Documented Bilateral Oophorectomy Post menopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.
Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until one week after the last dose of study medication.
Vasectomy with documentation of azoospermia, or Male condom plus partner use of one of the contraceptive options following: Contraceptive subdermal implant that meets the standard operating procedure (SOP) effectiveness criteria including a <1% rate of failure per year, as stated in the product label; Intrauterine device or intrauterine system that meets the SOP effectiveness criteria including a <1% rate of failure per year, as stated in the product label; Oral Contraceptive, either combined or progestogen alone. Injectable progestogen; Contraceptive vaginal ring; Percutaneous contraceptive patches.
These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The Investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
Capable of giving signed informed consent as described in Study protocol which includes compliance with the requirements and restrictions listed in the consent form and in protocol.

Who cannot join

Alanine aminotransferase and bilirubin >1.0* upper limit of normal (ULN).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities.
Subjects who have asthma or a history of asthma.
Medical history of cardiac arrhythmias or cardiac disease or a family and personal history of long QT syndrome
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 regular alcohol consumption within 6 months of the study defined as: For US sites: an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 grams (g) of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150mL) of wine or 1.5 ounces (45mL) of 80 proof distilled spirits.

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Regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
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 Medical Monitor, contraindicates their participation
Presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
Screening or baseline cardiac troponin I greater than the 99% cut-off (>.045 nanograms/mL by the Dimension Vista Cardiac troponin assay) for a given assay.
A positive pre-study drug/alcohol screen.
A positive test for HIV antibody.
Where participation in the study would result in donation of blood or blood products in excess of 500mL within 56 days.
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.
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], Wolf Parkinson White (WPW) syndrome etc.).
Sinus Pauses > 3 seconds. 300 or more supraventricular ectopic beats in 24 hours. 250 or more ventricular ectopic beats in 24 hours.
Any clinically significant abnormal echocardiogram finding. Abnormal echocardiogram findings should be discussed with the Medical Monitor prior to enrolment.
Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination):
Heart rate for Males <45 and >100 beats per minute (bpm), for females <50 and >100bpm PR Interval <120 and >220 millisecond (msec) QRS duration <70 and >120msec QT interval corrected (Fridericia's) >450msec

Trial locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
Baltimore, Maryland, 21225

Other trials in United States

About this study

Official title: A Double-Blind (Sponsor Unblinded), Randomized, Placebo-Controlled, Continuation Single and Repeated Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK2838232 With Ritonavir, in Healthy Subjects

GSK2838232 is a Human Immunodeficiency Virus (HIV) maturation inhibitor being developed for the treatment of HIV in combination with other antiretroviral therapy (ART). The primary objectives of this study are to investigate the safety, tolerability, and pharmacokinetics (PK) of single and repeat doses of GSK2838232. This study will be a double-blind, placebo-controlled, single and repeat dose escalation study. This study will be conducted in two Parts: single escalating doses (Part 1A and 1B), and repeated escalating once daily (QD) doses for 11 days (Part 2) of GSK2838232 co-dosed with RTV. During Part 1A, single doses of GSK2838232 (as of active pharmaceutical ingredient-powder in bottle [API PiB]) 50 milligrams (mg), 100mg and 200mg will be administered with RTV. Part 1B will evaluate the relative bioavailability of single doses of crystalline active pharmaceutical ingredient (API) Immediate Release Tablet (IR) tablets versus API PiB as reference, administered with RTV. In Part 2, multiple doses of GSK2838232 will be co-administered with RTV 100mg QD for 11 days as sequential dose cohorts. Maximum duration of study participation will be approximately 10 weeks.

Conditions: Infection, Human Immunodeficiency Virus
Being tested: GSK2838232 PIB, GSK2838232 IR1, GSK2838232 IR2, Placebo PIB, Ritonavir
Keywords: GSK2838232, HIV, repeated dose escalation, immediate release tablet, single dose escalation
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.

GSK2838232 PIBDrug
GSK2838232 will be available as oral suspension for reconstitution, will be administered as 50, 100 and 200 mg in Part A and as 20, 50, 100 or 200 mg in Part B.
GSK2838232 IR1Drug
GSK2838232 will be available as film-coated tablet for oral use
GSK2838232 IR2Drug
GSK2838232 will be available as film-coated tablet for oral use
Placebo PIBDrug
Oral suspension of hydromellulose acetate succinate will be supplied as powder-in-bottle for reconstitution.
RitonavirDrug
It is to be purchased by site. It will be white film-coated ovaloid tablets for oral administration.

Study groups in NCT02795754
Study group	Role	What they receive
GSK2838232 PIB (50 mg+100 mg+200 mg)+Placebo	Experimental	During Part 1A, subjects will receive QD single dose of either GSK2838232 50 mg, 100 mg or 200 mg or placebo in each of the four visits (one treatment per visit).Subjects will also receive RTV along with all the doses and QD RTV for 48hours (2 doses) before all doses of GSK2838232 and placebo. Receives: Drug: GSK2838232 PIB; Drug: Placebo PIB; Drug: Ritonavir
GSK2838232 PIB+IR1+IR2	Experimental	During Part 1B, subjects will receive either GSK2838232 PIB, GSK2838232 IR1 or IR2 in each of the three visits (one treatment per visit) after at least 10 hours fasting and IR1 or IR2 after fat meal at visit 4. Receives: Drug: GSK2838232 PIB; Drug: GSK2838232 IR1; Drug: GSK2838232 IR2; Drug: Ritonavir
GSK2838232 PIB (20mg/50 mg/100 mg/200 mg)/Placebo	Experimental	During Part 2, subjects will receive repeated QD doses of either GSK2838232 (20 mg, 50 mg, 100 mg or 200 mg) or placebo for 11 days. Subjects will also receive RTV along with all the doses of GSK2838232 and placebo. Receives: Drug: GSK2838232 PIB; Drug: Placebo PIB; Drug: Ritonavir

What is being measured

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

Number of participants with adverse events (AEs)
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Approximately 10 weeks
Safety as assessed by absolute values and change from Baseline in hematology parameters -Part 1
Hematology parameters includes platelet count, red blood cells (RBC) count, mean corpuscular volume (MCV), neutrophils, white blood cells (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, reticulocyte count, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. Hematology parameters will be evaluated at Day -2, Day -1, Day 2, Day 4, Day 14 of each visit.
Measured: Baseline (Day -1) and up to 10 weeks
Safety as assessed by absolute values and change from Baseline in hematology parameters - Part 2
Hematology parameters includes platelet count, RBC count, MCV, neutrophils, WBC count (absolute), MCH, lymphocytes, reticulocyte count, MCHC, monocytes, hemoglobin, eosinophils, hematocrit and basophils. Hematology parameters will be evaluated at Day -1, Day 2, Day 4, day 8, Day 11, Day 14, Day 17, Day 31 for each cohort
Measured: Baseline (Day-1) and up to Day 31 for each cohort.
Safety as assessed by absolute values and change from Baseline in clinical chemistry parameters -Part 1
Clinical chemistry parameters includes blood urine nitrogen (BUN), potassium, aspartate aminotransferase (AST), Lipase, Creatinine, Sodium, alanine aminotransferase (ALT), total protein, glucose, chloride, alkaline phosphatase, albumin, magnesium, total carbon dioxide (CO2), total and direct bilirubin, uric acid, calcium, phosphorus and gamma-glutamyl transferase (GGT). Clinical chemistry parameters will be evaluated at Day -2, Day -1, Day 2, Day 4, Day 14 of each visit.
Measured: Baseline (Day -1) and up to 10 weeks
Safety as assessed by absolute values and change from Baseline in clinical chemistry parameters- Part 2
Clinical chemistry parameters includes BUN, potassium, AST, lipase, creatinine, sodium, ALT, total protein, glucose, chloride, alkaline phosphatase, albumin, magnesium, total CO2, total and direct bilirubin, uric acid, calcium, phosphorus and GGT. Clinical chemistry parameters will be evaluated at Day -1, Day 2, Day 4, day 8, Day 11, Day 14, Day 17, Day 31 for each cohort
Measured: Baseline (Day-1) and up to Day 31 for each cohort.
Safety as assessed by absolute values and change from Baseline in urinalysis parameters-Part 1
Urinalysis parameters includes specific gravity, pH, glucose, protein, blood and ketones by dipstick, microscopic examination. Urinalysis parameters will be evaluated at Day -2, Day -1, Day 2, Day 4, Day 14 of each visit.
Measured: Baseline (Day -1) and up to 10 weeks
Safety as assessed by absolute values and change from Baseline in urinalysis parameters-Part 2
Urinalysis parameters includes specific gravity, pH, glucose, protein, blood and ketones by dipstick, microscopic examination. Urinalysis parameters will be evaluated at Day -1, Day 2, Day 4, Day 11, Day 14, Day 17, Day 31 for each cohort
Measured: Baseline (Day-1) and up to Day 31 for each cohort.
Safety as assessed by Blood pressure-Part 1
Systolic and diastolic blood pressure will be measured on Day 1, pre-dose (triplicate) and 1, 2, 4, 6, 8, 12, 24, 48, and 72hr post-dose during each visit.
Measured: 10 weeks
Safety as assessed by Heart rate -Part 1
Heart rate will be measured on Day 1, pre-dose (triplicate) and 1, 2, 4, 6, 8, 12, 24, 48, and 72hr post-dose during each visit.
Measured: 10 weeks
Safety as assessed by Blood pressure-Part 2
Systolic and diastolic blood pressure will be measured on Day -1, Day 1 at pre dose (triplicate), and 1hr, 4hr, 24hr, 48hr and 72hr post dose, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11 at pre dose (triplicate), and 1hr, 4hr, 24hr, 48hr and 72hr post dose and at follow up during each cohort.
Measured: 31 days in each cohort
Safety as assessed by Heart rate -Part 2
Heart rate will be measured on Day -1, Day 1 at pre dose (triplicate), and 1hr, 4hr, 24hr, 48hr and 72hr post dose, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11 at pre dose (triplicate), and 1hr, 4hr, 24hr, 48hr and 72hr post dose and at follow up during each cohort.
Measured: 31 days in each cohort
Safety as assessed by Electrocardiogram (ECG) parameters-Part 1
12-lead ECG will be conducted pre-dose on Day 1 (triplicate), and 1, 2, 4, 6, 8, 12, 24, 48 72 hour post dose.
Measured: Up to 10 weeks
Safety as assessed by ECG parameters-Part 2
A single 12-Lead ECG will be conducted at screening and Day -1, Day 1 at pre dose (triplicate), and 1 hour, 12 hour, 24hour, 48 hour and 72 hour post dose, Day 5, Day 8 and Day 11 at pre dose (triplicate), and 1 hr, 12 hour, 24 hour, 48 hour, and 72 hour post dose and at follow up during each cohort.
Measured: 31 days in for each cohort
Area under the concentration-time curve from time zero (pre-dose) to 24 hours (AUC[0-24]), Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC [0-inf]) in Part 1
Measured: Plasma samples will be collected pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose at each study visit
Apparent oral clearance (CL/F) for single dose GSK2838232 in Part 1A
Measured: Plasma samples will be collected pre-dose (within 15 minutes [min]prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose at each study visit during Part 1A.
Area under the concentration-time curve over the dosing interval (AUC[0 tau]) for repeated dose GSK2838232 in Part 2
Measured: Day 1; pre-dose (within 15 min prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hr post dose.On Day 11; pre-dose (within 15 min prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hr post dose
Apparent oral clearance (CL/F) for repeated dose GSK2838232 in Part 2
Measured: Plasma samples will be collected on Day 11; pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post dose.
Tmax for repeated dose GSK2838232 in Part 2
Measured: Day 1; pre-dose (within 15 min prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hr post dose. On Day 11; pre-dose (within 15 min prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96,120 and 144 hr post dose
Tlag for repeated dose GSK2838232 in Part 2
Measured: Day 1; pre-dose (within 15 min prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hr post dose. On Day 11; pre-dose (within 15 min prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96,120 and 144 hr post dose
T1/2 for repeated dose GSK2838232 in Part 2
Measured: Day 1; pre-dose (within 15 min prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hr post dose. On Day 11; pre-dose (within 15 min prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96,120 and 144 hr post dose
Tlast for repeated dose GSK2838232 in Part 2
Measured: Day 1; pre-dose (within 15 min prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hr post dose. On Day 11; pre-dose (within 15 min prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96,120 and 144 hr post dose
Maximum observed concentration (Cmax) in Part 1
Measured: Plasma samples will be collected pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose at each study visit
Concentration at 24 hours post dose (C24) in Part 1
Measured: Plasma samples will be collected pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose at each study visit
Last measurable concentration (Clast) in Part 1
Measured: Plasma samples will be collected pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose at each study visit
Time of occurence of Cmac (tmax) in Part 1
Measured: Plasma samples will be collected pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose at each study visit
Lag time before observation of drug concentrations in sampled matrix (tlag) in Part 1
Measured: Plasma samples will be collected pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose at each study visit
Terminal phase half life (t1/2) in Part 1
Measured: Plasma samples will be collected pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose at each study visit
Time of last observed quantifiable concentration (t-last) in Part 1
Measured: Plasma samples will be collected pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose at each study visit
Cmax of GSK2826232 in Part 2
Measured: Day 1; pre-dose (within 15 min prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hr post dose.On Day 11; pre-dose (within 15 min prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hr post dose
Clast of GSK2826232 in Part 2
Measured: Day 1; pre-dose (within 15 min prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hr post dose.On Day 11; pre-dose (within 15 min prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hr post dose
Concentration-time curve over the dosing interval (Ctau) of GSK2838232 in Part 2
Measured: Day 1; pre-dose (within 15 min prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hr post dose.On Day 11; pre-dose (within 15 min prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hr post dose

Secondary outcomes (9)

AUC (0-inf) in Part 1
Measured: Plasma samples will be collected pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose at each study visit
Cmax in Part 1
Measured: Plasma samples will be collected pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose at each study visit
AUC(0-tau) in Part 2
Measured: Day 1 pre-dose; 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hr post dose. Days 3-10 pre-dose; Day 11; pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hr post dose; all pre-dose within 15 min prior to dosing
Cmax in Part 2
Measured: Day 1 pre-dose; 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hr post dose. Days 3-10 pre-dose; Day 11; pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hr post dose; all pre-dose within 15 min prior to dosing
Ctau in Part 2
Measured: Day 1 pre-dose; 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hr post dose. Days 3-10 pre-dose; Day 11; pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hr post dose; all pre-dose within 15 min prior to dosing
Pre-dose GSK2838232 plasma concentrations on Day 2-11 in Part 2
Measured: Up to Day 11
Accumulation ratios (Ro) for AUC (0-tau)
Measured: Day 1 pre-dose; 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hr post dose. Days 3-10 pre-dose; Day 11; pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hr post dose; all pre-dose within 15 min prior to dosing
Accumulation ratios (Ro) for Cmax
Measured: Day 1 pre-dose; 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hr post dose. Days 3-10 pre-dose; Day 11; pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hr post dose; all pre-dose within 15 min prior to dosing
Accumulation ratios (Ro) for Ctau (where tau is 24 hours)
Measured: Day 1 pre-dose; 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hr post dose. Days 3-10 pre-dose; Day 11; pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hr post dose; all pre-dose within 15 min prior to dosing

Timeline

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

Mar 2016Dec 2016

First posted10 Jun 2016 (estimated)
Study startMar 2016
Primary completionDec 2016
Study completionDec 2016

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: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02795754
Sponsor's protocol ID: 204953
Status last verified: Jan 2017
First submitted: 21 Jan 2016
Last updated: 18 Jan 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind (Sponsor Unblinded), Randomized, Placebo-Controlled, Continuation Single and Repeated Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK2838232 With Ritonavir, in Healthy Subjects
ClinicalTrials.gov ID: NCT02795754
Acronym / sponsor ID: 204953
Conditions: Infection, Human Immunodeficiency Virus
Keywords: GSK2838232, HIV, repeated dose escalation, immediate release tablet, single dose escalation
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Mar 2016
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 10 Jun 2016 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
GSK2838232 PIB (50 mg+100 mg+200 mg)+Placebo	Experimental	Drug: GSK2838232 PIB, Drug: Placebo PIB, Drug: RitonavirDuring Part 1A, subjects will receive QD single dose of either GSK2838232 50 mg, 100 mg or 200 mg or placebo in each of the four visits (one treatment per visit).Subjects will also receive RTV along with all the doses and QD RTV for 48hours (2 doses) before all doses of GSK2838232 and placebo.
GSK2838232 PIB+IR1+IR2	Experimental	Drug: GSK2838232 PIB, Drug: GSK2838232 IR1, Drug: GSK2838232 IR2, Drug: RitonavirDuring Part 1B, subjects will receive either GSK2838232 PIB, GSK2838232 IR1 or IR2 in each of the three visits (one treatment per visit) after at least 10 hours fasting and IR1 or IR2 after fat meal at visit 4.
GSK2838232 PIB (20mg/50 mg/100 mg/200 mg)/Placebo	Experimental	Drug: GSK2838232 PIB, Drug: Placebo PIB, Drug: RitonavirDuring Part 2, subjects will receive repeated QD doses of either GSK2838232 (20 mg, 50 mg, 100 mg or 200 mg) or placebo for 11 days. Subjects will also receive RTV along with all the doses of GSK2838232 and placebo.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Age: Between 18 and 55 years of age inclusive, at the time of signing the informed consent.
Healthy as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, and outside the reference range for the population being studied, may be included only if the Investigator in consultation with the Medical Monitor, if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
A creatinine clearance (CLcr) >80milliliter/minute (mL/min) as determined by Cockcroft-Gault equation CLcr (mL/min) = (140 - age) * weight (Wt) / (72 * serum creatinine [Scr]) (times 0.85 if female) where age is in years, Wt is in kilogram (kg), and Scr is in units of milligram / decilitre (mg/dL);.
Body weight >= 50.0 kg (110 pounds [lbs.]) for men and >= 45.0kg (99lbs) for women and body mass index (BMI)

Key exclusion criteria (22 listed)

Alanine aminotransferase and bilirubin >1.0* upper limit of normal (ULN).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities.
Subjects who have asthma or a history of asthma.
Medical history of cardiac arrhythmias or cardiac disease or a family and personal history of long QT syndrome
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

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
GSK2838232 PIBGSK2838232 will be available as oral suspension for reconstitution, will be administered as 50, 100 and 200 mg in Part A and as 20, 50, 100 or 200 mg in Part B.	Drug	GSK2838232 PIB (20mg/50 mg/100 mg/200 mg)/Placebo, GSK2838232 PIB (50 mg+100 mg+200 mg)+Placebo, GSK2838232 PIB+IR1+IR2
GSK2838232 IR1GSK2838232 will be available as film-coated tablet for oral use	Drug	GSK2838232 PIB+IR1+IR2
GSK2838232 IR2GSK2838232 will be available as film-coated tablet for oral use	Drug	GSK2838232 PIB+IR1+IR2
Placebo PIBOral suspension of hydromellulose acetate succinate will be supplied as powder-in-bottle for reconstitution.	Drug	GSK2838232 PIB (20mg/50 mg/100 mg/200 mg)/Placebo, GSK2838232 PIB (50 mg+100 mg+200 mg)+Placebo
RitonavirIt is to be purchased by site. It will be white film-coated ovaloid tablets for oral administration.	Drug	GSK2838232 PIB (20mg/50 mg/100 mg/200 mg)/Placebo, GSK2838232 PIB (50 mg+100 mg+200 mg)+Placebo, GSK2838232 PIB+IR1+IR2

Primary outcome

Number of participants with adverse events (AEs)
Time frame: Approximately 10 weeks
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Safety as assessed by absolute values and change from Baseline in hematology parameters -Part 1
Time frame: Baseline (Day -1) and up to 10 weeks
Hematology parameters includes platelet count, red blood cells (RBC) count, mean corpuscular volume (MCV), neutrophils, white blood cells (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, reticulocyte count, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. Hematology parameters will be evaluated at Day -2, Day -1, Day 2, Day 4, Day 14 of each visit.
Safety as assessed by absolute values and change from Baseline in hematology parameters - Part 2
Time frame: Baseline (Day-1) and up to Day 31 for each cohort.
Hematology parameters includes platelet count, RBC count, MCV, neutrophils, WBC count (absolute), MCH, lymphocytes, reticulocyte count, MCHC, monocytes, hemoglobin, eosinophils, hematocrit and basophils. Hematology parameters will be evaluated at Day -1, Day 2, Day 4, day 8, Day 11, Day 14, Day 17, Day 31 for each cohort
Safety as assessed by absolute values and change from Baseline in clinical chemistry parameters -Part 1
Time frame: Baseline (Day -1) and up to 10 weeks
Clinical chemistry parameters includes blood urine nitrogen (BUN), potassium, aspartate aminotransferase (AST), Lipase, Creatinine, Sodium, alanine aminotransferase (ALT), total protein, glucose, chloride, alkaline phosphatase, albumin, magnesium, total carbon dioxide (CO2), total and direct bilirubin, uric acid, calcium, phosphorus and gamma-glutamyl transferase (GGT). Clinical chemistry parameters will be evaluated at Day -2, Day -1, Day 2, Day 4, Day 14 of each visit.
Safety as assessed by absolute values and change from Baseline in clinical chemistry parameters- Part 2
Time frame: Baseline (Day-1) and up to Day 31 for each cohort.
Clinical chemistry parameters includes BUN, potassium, AST, lipase, creatinine, sodium, ALT, total protein, glucose, chloride, alkaline phosphatase, albumin, magnesium, total CO2, total and direct bilirubin, uric acid, calcium, phosphorus and GGT. Clinical chemistry parameters will be evaluated at Day -1, Day 2, Day 4, day 8, Day 11, Day 14, Day 17, Day 31 for each cohort
Safety as assessed by absolute values and change from Baseline in urinalysis parameters-Part 1
Time frame: Baseline (Day -1) and up to 10 weeks
Urinalysis parameters includes specific gravity, pH, glucose, protein, blood and ketones by dipstick, microscopic examination. Urinalysis parameters will be evaluated at Day -2, Day -1, Day 2, Day 4, Day 14 of each visit.
Safety as assessed by absolute values and change from Baseline in urinalysis parameters-Part 2
Time frame: Baseline (Day-1) and up to Day 31 for each cohort.
Urinalysis parameters includes specific gravity, pH, glucose, protein, blood and ketones by dipstick, microscopic examination. Urinalysis parameters will be evaluated at Day -1, Day 2, Day 4, Day 11, Day 14, Day 17, Day 31 for each cohort
Safety as assessed by Blood pressure-Part 1
Time frame: 10 weeks
Systolic and diastolic blood pressure will be measured on Day 1, pre-dose (triplicate) and 1, 2, 4, 6, 8, 12, 24, 48, and 72hr post-dose during each visit.
Safety as assessed by Heart rate -Part 1
Time frame: 10 weeks
Heart rate will be measured on Day 1, pre-dose (triplicate) and 1, 2, 4, 6, 8, 12, 24, 48, and 72hr post-dose during each visit.
Safety as assessed by Blood pressure-Part 2
Time frame: 31 days in each cohort
Systolic and diastolic blood pressure will be measured on Day -1, Day 1 at pre dose (triplicate), and 1hr, 4hr, 24hr, 48hr and 72hr post dose, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11 at pre dose (triplicate), and 1hr, 4hr, 24hr, 48hr and 72hr post dose and at follow up during each cohort.
Safety as assessed by Heart rate -Part 2
Time frame: 31 days in each cohort
Heart rate will be measured on Day -1, Day 1 at pre dose (triplicate), and 1hr, 4hr, 24hr, 48hr and 72hr post dose, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11 at pre dose (triplicate), and 1hr, 4hr, 24hr, 48hr and 72hr post dose and at follow up during each cohort.
Safety as assessed by Electrocardiogram (ECG) parameters-Part 1
Time frame: Up to 10 weeks
12-lead ECG will be conducted pre-dose on Day 1 (triplicate), and 1, 2, 4, 6, 8, 12, 24, 48 72 hour post dose.
Safety as assessed by ECG parameters-Part 2
Time frame: 31 days in for each cohort
A single 12-Lead ECG will be conducted at screening and Day -1, Day 1 at pre dose (triplicate), and 1 hour, 12 hour, 24hour, 48 hour and 72 hour post dose, Day 5, Day 8 and Day 11 at pre dose (triplicate), and 1 hr, 12 hour, 24 hour, 48 hour, and 72 hour post dose and at follow up during each cohort.
Area under the concentration-time curve from time zero (pre-dose) to 24 hours (AUC[0-24]), Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC [0-inf]) in Part 1
Time frame: Plasma samples will be collected pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose at each study visit
Apparent oral clearance (CL/F) for single dose GSK2838232 in Part 1A
Time frame: Plasma samples will be collected pre-dose (within 15 minutes [min]prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose at each study visit during Part 1A.
Area under the concentration-time curve over the dosing interval (AUC[0 tau]) for repeated dose GSK2838232 in Part 2
Time frame: Day 1; pre-dose (within 15 min prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hr post dose.On Day 11; pre-dose (within 15 min prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hr post dose
Apparent oral clearance (CL/F) for repeated dose GSK2838232 in Part 2
Time frame: Plasma samples will be collected on Day 11; pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post dose.
Tmax for repeated dose GSK2838232 in Part 2
Time frame: Day 1; pre-dose (within 15 min prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hr post dose. On Day 11; pre-dose (within 15 min prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96,120 and 144 hr post dose
Tlag for repeated dose GSK2838232 in Part 2
Time frame: Day 1; pre-dose (within 15 min prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hr post dose. On Day 11; pre-dose (within 15 min prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96,120 and 144 hr post dose
T1/2 for repeated dose GSK2838232 in Part 2
Time frame: Day 1; pre-dose (within 15 min prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hr post dose. On Day 11; pre-dose (within 15 min prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96,120 and 144 hr post dose
Tlast for repeated dose GSK2838232 in Part 2
Time frame: Day 1; pre-dose (within 15 min prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hr post dose. On Day 11; pre-dose (within 15 min prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96,120 and 144 hr post dose
Maximum observed concentration (Cmax) in Part 1
Time frame: Plasma samples will be collected pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose at each study visit
Concentration at 24 hours post dose (C24) in Part 1
Time frame: Plasma samples will be collected pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose at each study visit
Last measurable concentration (Clast) in Part 1
Time frame: Plasma samples will be collected pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose at each study visit
Time of occurence of Cmac (tmax) in Part 1
Time frame: Plasma samples will be collected pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose at each study visit
Lag time before observation of drug concentrations in sampled matrix (tlag) in Part 1
Time frame: Plasma samples will be collected pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose at each study visit
Terminal phase half life (t1/2) in Part 1
Time frame: Plasma samples will be collected pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose at each study visit
Time of last observed quantifiable concentration (t-last) in Part 1
Time frame: Plasma samples will be collected pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose at each study visit
Cmax of GSK2826232 in Part 2
Time frame: Day 1; pre-dose (within 15 min prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hr post dose.On Day 11; pre-dose (within 15 min prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hr post dose
Clast of GSK2826232 in Part 2
Time frame: Day 1; pre-dose (within 15 min prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hr post dose.On Day 11; pre-dose (within 15 min prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hr post dose
Concentration-time curve over the dosing interval (Ctau) of GSK2838232 in Part 2
Time frame: Day 1; pre-dose (within 15 min prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hr post dose.On Day 11; pre-dose (within 15 min prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hr post dose

9 secondary outcomes

AUC (0-inf) in Part 1
Time frame: Plasma samples will be collected pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose at each study visit
Cmax in Part 1
Time frame: Plasma samples will be collected pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose at each study visit
AUC(0-tau) in Part 2
Time frame: Day 1 pre-dose; 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hr post dose. Days 3-10 pre-dose; Day 11; pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hr post dose; all pre-dose within 15 min prior to dosing
Cmax in Part 2
Time frame: Day 1 pre-dose; 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hr post dose. Days 3-10 pre-dose; Day 11; pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hr post dose; all pre-dose within 15 min prior to dosing
Ctau in Part 2
Time frame: Day 1 pre-dose; 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hr post dose. Days 3-10 pre-dose; Day 11; pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hr post dose; all pre-dose within 15 min prior to dosing
Pre-dose GSK2838232 plasma concentrations on Day 2-11 in Part 2
Time frame: Up to Day 11
Accumulation ratios (Ro) for AUC (0-tau)
Time frame: Day 1 pre-dose; 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hr post dose. Days 3-10 pre-dose; Day 11; pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hr post dose; all pre-dose within 15 min prior to dosing
Accumulation ratios (Ro) for Cmax
Time frame: Day 1 pre-dose; 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hr post dose. Days 3-10 pre-dose; Day 11; pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hr post dose; all pre-dose within 15 min prior to dosing
Accumulation ratios (Ro) for Ctau (where tau is 24 hours)
Time frame: Day 1 pre-dose; 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hr post dose. Days 3-10 pre-dose; Day 11; pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hr post dose; all pre-dose within 15 min prior to dosing

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 18 Jan 2017.

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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

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 PIB, GSK2838232 IR1 and GSK2838232 IR2 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 12 inclusion and 22 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 18 Jan 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 participants with adverse events (AEs) (time frame: Approximately 10 weeks). The study lists 31 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 NCT02795754.

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 18 Jan 2017.