Trial Outcomes & Findings for Positron Emission Tomography (PET) Study to Evaluate Biodistribution of [11C]-GSK2256098 in Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension (PAH) Patients (NCT NCT02551653)
NCT ID: NCT02551653
Last Updated: 2018-11-14
Results Overview
The PET scan was acquired to measure the uptake of radiolabeled GSK2256098 in the heart and lungs, assessed as the volume of distribution (VT). The analysis was performed on Safety Population which comprised of all participants who received a microdose of study treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
Day 1
Results posted on
2018-11-14
Participant Flow
Healthy volunteers and participants with Pulmonary Arterial Hypertension (PAH) were included in this study to evaluate the bio-distribution of \[11C\]- GSK2256098 in the lungs and heart using Positron Emission Tomography (PET).
A total of 14 participants were screened, of which 4 participants were screen failures. Remaining 10 participants were included in the study.
Participant milestones
| Measure |
PAH Participants
Participants received one microdose that is (i.e.) less than 10 micrograms of radiolabeled GSK2256098 in a 20 milliliter (mL) volume, via intravenous (IV) route. A PET scan was performed immediately after the IV administration.
|
Healthy Volunteers
Participants received one microdose i.e. less than 10 micrograms of radiolabeled GSK2256098 in a 20 mL volume, via IV route. A PET scan was performed immediately after the IV administration.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Positron Emission Tomography (PET) Study to Evaluate Biodistribution of [11C]-GSK2256098 in Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension (PAH) Patients
Baseline characteristics by cohort
| Measure |
PAH Participants
n=5 Participants
Participants received one microdose that is (i.e.) less than 10 micrograms of radiolabeled GSK2256098 in a 20 milliliter (mL) volume, via intravenous (IV) route. A PET scan was performed immediately after the IV administration.
|
Healthy Volunteers
n=5 Participants
Participants received one microdose i.e. less than 10 micrograms of radiolabeled GSK2256098 in a 20 mL volume, via IV route. A PET scan was performed immediately after the IV administration.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.2 Years
STANDARD_DEVIATION 5.81 • n=5 Participants
|
64.0 Years
STANDARD_DEVIATION 7.00 • n=7 Participants
|
63.6 Years
STANDARD_DEVIATION 6.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Heritage
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Safety Population
The PET scan was acquired to measure the uptake of radiolabeled GSK2256098 in the heart and lungs, assessed as the volume of distribution (VT). The analysis was performed on Safety Population which comprised of all participants who received a microdose of study treatment.
Outcome measures
| Measure |
PAH Participants
n=5 Participants
Participants received one microdose that is (i.e.) less than 10 micrograms of radiolabeled GSK2256098 in a 20 milliliter (mL) volume, via intravenous (IV) route. A PET scan was performed immediately after the IV administration.
|
Healthy Volunteers
n=5 Participants
Participants received one microdose i.e. less than 10 micrograms of radiolabeled GSK2256098 in a 20 mL volume, via IV route. A PET scan was performed immediately after the IV administration.
|
|---|---|---|
|
Volume of Distribution of Radiolabeled GSK2256098 Measured by PET Scan
Heart, left ventricular wall
|
1.0811 Milliliter per cubic centimeter(mL/cm^3)
Standard Deviation 0.14769
|
1.3027 Milliliter per cubic centimeter(mL/cm^3)
Standard Deviation 0.18754
|
|
Volume of Distribution of Radiolabeled GSK2256098 Measured by PET Scan
Heart, right ventricular wall
|
0.8117 Milliliter per cubic centimeter(mL/cm^3)
Standard Deviation 0.15253
|
0.5571 Milliliter per cubic centimeter(mL/cm^3)
Standard Deviation 0.12824
|
|
Volume of Distribution of Radiolabeled GSK2256098 Measured by PET Scan
Lung
|
0.0858 Milliliter per cubic centimeter(mL/cm^3)
Standard Deviation 0.02364
|
0.0904 Milliliter per cubic centimeter(mL/cm^3)
Standard Deviation 0.01592
|
PRIMARY outcome
Timeframe: Day 1Population: Safety Population
The PET scan was acquired to measure the uptake of radiolabeled GSK2256098 in the heart and lungs, assessed as the mean standardized uptake value (SUV) averaged over the 60 minute period between 30 and 90 minutes. The analysis was performed on Safety Population which comprised of all participants who received a microdose of study treatment.
Outcome measures
| Measure |
PAH Participants
n=5 Participants
Participants received one microdose that is (i.e.) less than 10 micrograms of radiolabeled GSK2256098 in a 20 milliliter (mL) volume, via intravenous (IV) route. A PET scan was performed immediately after the IV administration.
|
Healthy Volunteers
n=5 Participants
Participants received one microdose i.e. less than 10 micrograms of radiolabeled GSK2256098 in a 20 mL volume, via IV route. A PET scan was performed immediately after the IV administration.
|
|---|---|---|
|
Standardized Uptake Values (SUV) of Radiolabeled GSK2256098 Measured by PET Scan
Heart, left ventricular wall
|
1.0738 Grams per milliliter (g/mL)
Standard Deviation 0.04931
|
1.0697 Grams per milliliter (g/mL)
Standard Deviation 0.20070
|
|
Standardized Uptake Values (SUV) of Radiolabeled GSK2256098 Measured by PET Scan
Heart, right ventricular wall
|
1.0143 Grams per milliliter (g/mL)
Standard Deviation 0.10994
|
0.9689 Grams per milliliter (g/mL)
Standard Deviation 0.19018
|
|
Standardized Uptake Values (SUV) of Radiolabeled GSK2256098 Measured by PET Scan
Lung
|
0.2988 Grams per milliliter (g/mL)
Standard Deviation 0.05150
|
0.2891 Grams per milliliter (g/mL)
Standard Deviation 0.06851
|
Adverse Events
PAH Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Volunteers
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PAH Participants
n=5 participants at risk
Participants received one microdose that is (i.e.) less than 10 micrograms of radiolabeled GSK2256098 in a 20 milliliter (mL) volume, via intravenous (IV) route. A PET scan was performed immediately after the IV administration.
|
Healthy Volunteers
n=5 participants at risk
Participants received one microdose i.e. less than 10 micrograms of radiolabeled GSK2256098 in a 20 mL volume, via IV route. A PET scan was performed immediately after the IV administration.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected on Day 1 and up to 4 Weeks post-dose.
The analysis was performed on Safety Population.
|
60.0%
3/5 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected on Day 1 and up to 4 Weeks post-dose.
The analysis was performed on Safety Population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected on Day 1 and up to 4 Weeks post-dose.
The analysis was performed on Safety Population.
|
60.0%
3/5 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected on Day 1 and up to 4 Weeks post-dose.
The analysis was performed on Safety Population.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected on Day 1 and up to 4 Weeks post-dose.
The analysis was performed on Safety Population.
|
20.0%
1/5 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected on Day 1 and up to 4 Weeks post-dose.
The analysis was performed on Safety Population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER