Malaria, FalciparumPhase 1NCT02737007
A Microdose Study in Healthy Subjects to Describe Intravenous Pharmacokinetics of GSK3191607
A Phase 1 study testing [14C]-GSK3191607 in people with Malaria, Falciparum, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This is an open-label, single-centre, non-randomized study to investigate the pharmacokinetics of GSK3191607, administered as a single intravenous (IV) dose in healthy male subjects. Six subjects will be administered an IV microdose of radio-labeled [14C]-GSK3191607. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- [14C]-GSK3191607
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Apr 2016to 12 May 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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, vital signs, 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, outside the reference range for the population being studied may be included only if the investigator agrees and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Body weight >= 50 kg and body mass index (BMI) within the range 19.0-31.0 kilograms per meter squared (kg/m^2) (inclusive).
- Male.
- Subjects with female partners of child bearing potential must use a condom from the time of first dose of study medication until follow-up.
- Capable of giving signed informed consent, which includes compliance with pre-defined requirements and restrictions.
Who cannot join
- Alanine aminotransferase (ALT) and bilirubin >1.5 times upper limit of normal (ULN) (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Mean QT duration corrected for heart rate by Fridericia's formula (QTcF) > 450 milliseconds (msec).
- Any clinically relevant abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or 12-lead electrocardiogram (ECG).
- At screening, a mean supine blood pressure (BP) that is higher (triplicate measurements at least 2 minutes apart) than 140/90 millimeters of mercury (mmHg).
- At screening, a supine mean pulse rate outside the range 40-90 beats per minute (BPM).
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- Subject is mentally or legally incapacitated.
- 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) before 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.
- Smoking or use of tobacco products. Urinary cotinine levels indicative of use of tobacco products or nicotine-containing products.
- History of regular alcohol consumption within 6 months of the study, defined as an average weekly intake of >21 units. One unit is equivalent to 8 grams (g) of alcohol: a half pint (~240 milliliters [mL]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
- History of sensitivity to any of the study medication or its components, or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates the subject's participation.
- Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months before first dose of study treatment.
- A positive pre-study drug/alcohol screen.
- A positive test for Human immunodeficiency virus (HIV).
- Participation in a clinical trial involving administration of 14C-labelled compound(s) within the last 12 months before dosing. A subject's previous effective dose will be reviewed by the medical investigator to ensure there is no risk of contamination/carryover into the current study.
- Subjects who have received a total body radiation dose of greater than 5.0 millisieverts (mSv) (upper limit of World Health Organization [WHO] category II) or exposure to significant radiation (for example, serial x ray or Computed Tomography (CT) scans, barium meal, etc.) in the 12 months before dosing.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 90 day period.
- Unable to refrain from consumption of red wine, Seville oranges, grapefruit or grapefruit juice from 7 days before the first dose of study medication until the last study visit.
- The subject has participated in a clinical trial and has received an investigational product within the following time period before 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 before the first dosing day.
- An occupation which requires monitoring for radiation exposure, nuclear medicine procedures or excessive x-rays within the past 12 months before dosing.
- Unwillingness or inability to follow the procedures outlined in the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Microdose Study to Describe the Intravenous Pharmacokinetics of GSK3191607 in Healthy Male Subjects Following Administration of [14C]-GSK3191607
This is an open-label, single-centre, non-randomized study to investigate the pharmacokinetics of GSK3191607, administered as a single intravenous (IV) dose in healthy male subjects.
Six subjects will be administered an IV microdose of radio-labeled [14C]-GSK3191607. The study will provide an early readout on human pharmacokinetic parameters. The results of this study will be used to estimate the potential duration of anti-parasite effect in humans, define predicted clinical oral doses, and hence inform about the compound's potential safety margin.
Each subject will participate in the study for up to 8 weeks, and will have a screening visit, one treatment period, eight outpatient visits, and a follow-up visit.
- Conditions
- Malaria, Falciparum
- Being tested
- [14C]-GSK3191607
- Keywords
- Malaria, Microdose, GSK3191607
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-GSK3191607Drug
[14C]-GSK3191607 is a solution to be administered intravenously as a single dose infusion over 15 minutes. It is a radio-labeled product; 100 mcg of [14C]-GSK3191607 contains approximately 7.4 kilobecquerel (kBq) of [14C] radioactivity.
| Study group | Role | What they receive |
|---|---|---|
| [14C]-GSK3191607 IV Microdose | Experimental | Subjects will receive a single microdose of 100 micrograms (mcg) of [14C]-GSK3191607 by intravenous infusion over 15 minutes on Day 1 of the study. Receives: Drug: [14C]-GSK3191607 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax) of GSK3191607 in plasma following a single intravenous (IV) microdose
Measured: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Terminal phase half life (t1/2) of GSK3191607 following a single IV microdose
Measured: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Time of occurrence of Cmax (tmax) of GSK3191607 following a single IV microdose
Measured: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
AUC(0-t) of GSK3191607 following a single IV microdose
AUC(0-t) is the area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration.
Measured: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
AUC(0-infinity) of GSK3191607 following a single IV microdose
AUC(0-infinity) is the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time.
Measured: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Systemic clearance (CL) of GSK3191607 following a single IV microdose
Measured: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
GSK3191607 volume of distribution at steady state (Vss)
Measured: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Cmax of radioactive drug-related material (RDM) in plasma following a single IV microdose of [14C]-GSK3191607
RDM is a measure of total radioactivity. Cmax of RDM will be compared with that of the parent drug (GSK3191607).
Measured: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
T1/2 of RDM following a single IV microdose of [14C]-GSK3191607
T1/2 of RDM will be compared with that of the parent drug.
Measured: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Tmax of RDM following a single IV microdose of [14C]-GSK3191607
Tmax of RDM will be compared with that of the parent drug.
Measured: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
AUC(0-t) of RDM following a single IV microdose of [14C]-GSK3191607
AUC(0-t) of RDM will be compared with that of the parent drug.
Measured: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
AUC(0-infinity) of RDM following a single IV microdose of [14C]-GSK3191607
AUC(0-infinity) of RDM will be compared with that of the parent drug.
Measured: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Amount of RDM excreted in urine (Ae) following a single IV microdose of [14C]-GSK3191607
Subjects will be asked to void their bladders before study treatment administration. A blank urine sample will be collected pre-dose.
Measured: Pre-dose; and 0-24 hours and 24-48 hours after the start of infusion
Secondary outcomes (9)
Whole-Blood:Plasma ratio of Cmax of RDM following a single IV microdose of [14C]-GSK3191607
Cmax of RDM in whole blood will be compared with that of RDM in plasma.
Measured: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Whole-Blood:Plasma ratio of tmax of RDM following a single IV microdose of [14C]-GSK3191607
Tmax of RDM in whole blood will be compared with that of RDM in plasma.
Measured: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Whole-Blood:Plasma ratio of t1/2 of RDM following a single IV microdose of [14C]-GSK3191607
T1/2 of RDM in whole blood will be compared with that of RDM in plasma.
Measured: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Whole-Blood:Plasma ratio of AUC(0-t) of RDM following a single IV microdose of [14C]-GSK3191607
AUC(0-t) of RDM in whole blood will be compared with that of RDM in plasma.
Measured: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Whole-Blood:Plasma ratio of AUC(0-infinity) of RDM following a single IV microdose of [14C]-GSK3191607
AUC(0-infinity) of RDM in whole blood will be compared with that of RDM in plasma.
Measured: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Number of subjects with adverse events
Measured: Start of infusion until follow-up (up to Day 25)
Number of subjects with clinically significant abnormal laboratory parameters
Hematology, clinical chemistry, and urinalysis parameters will be evaluated.
Measured: Day -1, Day 1, Day 2, and follow-up (up to Day 25)
Number of subjects with clinically significant abnormal 12-lead electrocardiogram (ECG) parameters
12-lead ECGs will be obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT duration corrected for heart rate by Bazett's formula (QTcB) intervals.
Measured: Pre-dose, Day 1, Day 2, and follow-up (up to Day 25)
Number of subjects with clinically significant abnormal vital signs parameters
Vital signs will be measured in a semi-supine position after 5 minutes rest and will include systolic and diastolic blood pressure and pulse rate.
Measured: Pre-dose, Day 1, Day 2, Day 3, and follow-up (up to Day 25)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study start18 Apr 2016
- Primary completion12 May 2016
- Study completion12 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria, FalciparumStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hammersmith Medicines Research
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737007
- Sponsor's protocol ID
- 204853
- Status last verified
- Sep 2018
- First submitted
- 31 Mar 2016
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Microdose Study to Describe the Intravenous Pharmacokinetics of GSK3191607 in Healthy Male Subjects Following Administration of [14C]-GSK3191607
- ClinicalTrials.gov ID
- NCT02737007
- Acronym / sponsor ID
- 204853
- Conditions
- Malaria, Falciparum
- Keywords
- Malaria, Microdose, GSK3191607
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Hammersmith Medicines Research
- Study start
- 18 Apr 2016 (actual)
- Primary completion
- 12 May 2016 (actual)
- Study completion
- 12 May 2016 (actual)
- First posted
- 13 Apr 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.
This is an open-label, single-centre, non-randomized study to investigate the pharmacokinetics of GSK3191607, administered as a single intravenous (IV) dose in healthy male subjects.
Six subjects will be administered an IV microdose of radio-labeled [14C]-GSK3191607. The study will provide an early readout on human pharmacokinetic parameters. The results of this study will be used to estimate the potential duration of anti-parasite effect in humans, define predicted clinical oral doses, and hence inform about the compound's potential safety margin.
Each subject will participate in the study for up to 8 weeks, and will have a screening visit, one treatment period, eight outpatient visits, and a follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-GSK3191607 IV Microdose | Experimental | Drug: [14C]-GSK3191607Subjects will receive a single microdose of 100 micrograms (mcg) of [14C]-GSK3191607 by intravenous infusion over 15 minutes on Day 1 of the study. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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, vital signs, 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, outside the reference range for the population being studied may be included only if the investigator agrees and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Body weight >= 50 kg and body mass index (BMI) within the range 19.0-31.0 kilograms per meter squared (kg/m^2) (inclusive).
- Male.
- Subjects with female partners of child bearing potential must use a condom from the time of first dose of study medication until follow-up.
Key exclusion criteria (22 listed)
- Alanine aminotransferase (ALT) and bilirubin >1.5 times upper limit of normal (ULN) (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Mean QT duration corrected for heart rate by Fridericia's formula (QTcF) > 450 milliseconds (msec).
- Any clinically relevant abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or 12-lead electrocardiogram (ECG).
- At screening, a mean supine blood pressure (BP) that is higher (triplicate measurements at least 2 minutes apart) than 140/90 millimeters of mercury (mmHg).
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 |
|---|---|---|
| [14C]-GSK3191607[14C]-GSK3191607 is a solution to be administered intravenously as a single dose infusion over 15 minutes. It is a radio-labeled product; 100 mcg of [14C]-GSK3191607 contains approximately 7.4 kilobecquerel (kBq) of [14C] radioactivity. | Drug | [14C]-GSK3191607 IV Microdose |
Primary outcome
Maximum observed concentration (Cmax) of GSK3191607 in plasma following a single intravenous (IV) microdose
Time frame: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Terminal phase half life (t1/2) of GSK3191607 following a single IV microdose
Time frame: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Time of occurrence of Cmax (tmax) of GSK3191607 following a single IV microdose
Time frame: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
AUC(0-t) of GSK3191607 following a single IV microdose
Time frame: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
AUC(0-t) is the area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration.
AUC(0-infinity) of GSK3191607 following a single IV microdose
Time frame: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
AUC(0-infinity) is the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time.
Systemic clearance (CL) of GSK3191607 following a single IV microdose
Time frame: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
GSK3191607 volume of distribution at steady state (Vss)
Time frame: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Cmax of radioactive drug-related material (RDM) in plasma following a single IV microdose of [14C]-GSK3191607
Time frame: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
RDM is a measure of total radioactivity. Cmax of RDM will be compared with that of the parent drug (GSK3191607).
T1/2 of RDM following a single IV microdose of [14C]-GSK3191607
Time frame: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
T1/2 of RDM will be compared with that of the parent drug.
Tmax of RDM following a single IV microdose of [14C]-GSK3191607
Time frame: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Tmax of RDM will be compared with that of the parent drug.
AUC(0-t) of RDM following a single IV microdose of [14C]-GSK3191607
Time frame: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
AUC(0-t) of RDM will be compared with that of the parent drug.
AUC(0-infinity) of RDM following a single IV microdose of [14C]-GSK3191607
Time frame: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
AUC(0-infinity) of RDM will be compared with that of the parent drug.
Amount of RDM excreted in urine (Ae) following a single IV microdose of [14C]-GSK3191607
Time frame: Pre-dose; and 0-24 hours and 24-48 hours after the start of infusion
Subjects will be asked to void their bladders before study treatment administration. A blank urine sample will be collected pre-dose.
9 secondary outcomes
Whole-Blood:Plasma ratio of Cmax of RDM following a single IV microdose of [14C]-GSK3191607
Time frame: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Whole-Blood:Plasma ratio of tmax of RDM following a single IV microdose of [14C]-GSK3191607
Time frame: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Whole-Blood:Plasma ratio of t1/2 of RDM following a single IV microdose of [14C]-GSK3191607
Time frame: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Whole-Blood:Plasma ratio of AUC(0-t) of RDM following a single IV microdose of [14C]-GSK3191607
Time frame: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Whole-Blood:Plasma ratio of AUC(0-infinity) of RDM following a single IV microdose of [14C]-GSK3191607
Time frame: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Number of subjects with adverse events
Time frame: Start of infusion until follow-up (up to Day 25)
Number of subjects with clinically significant abnormal laboratory parameters
Time frame: Day -1, Day 1, Day 2, and follow-up (up to Day 25)
Number of subjects with clinically significant abnormal 12-lead electrocardiogram (ECG) parameters
Time frame: Pre-dose, Day 1, Day 2, and follow-up (up to Day 25)
Number of subjects with clinically significant abnormal vital signs parameters
Time frame: Pre-dose, Day 1, Day 2, Day 3, and follow-up (up to Day 25)
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 13 Sep 2018.
- Results for study 204853 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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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 [14C]-GSK3191607 in people with Malaria, Falciparum, run by GlaxoSmithKline at 1 site in United Kingdom.
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 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 13 Sep 2018. 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 Kingdom. 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?
Maximum observed concentration (Cmax) of GSK3191607 in plasma following a single intravenous (IV) microdose (time frame: Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion). The study lists 13 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 13 Sep 2018.