Huntington DiseasePhase 1NCT01602900
Healthy Volunteer Positron Emission Tomography (PET) Brain Occupancy Study of a Phosphodiesterase 4 (PDE4) Inhibitor in Huntington's Disease
A Phase 1 study testing GSK356278 and Rolipram in people with Huntington Disease, run by GlaxoSmithKline at 2 sites in United Kingdom.
Trial summary
This study will investigate if a new experimental drug to treat Huntington's Disease gets into the brain. If it does get into the brain the study will explore the relationship between the amount of drug in the brain and the amount of drug in the blood. The study will involve healthy male volunteers. Read more about this study
- Who is it for?
- Ages 22 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease
- What is being tested?
- GSK356278 and Rolipram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 22 Nov 2011to 12 Apr 2012
- 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 22 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteer, aged 22-55 years.
- Normal blood pressure, laboratory values, and body mass index
- Willing to agree to study procedures \& contraception requirements
- Capable of giving written informed consent
Who cannot join
- Any evidence of disease that would preclude participation in the clinical study (includes sexually transmitted diseases, exessive alcohol consumption, and substance abuse).
- Previously involved in another clinical trial within 3 months prior to scheduled administration of study drug
- Smoker
- Suffers from claustrophobia
- Any contraindications for MRI scanning (e.g. pacemaker, metal implants or fillings)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
GSK Investigational Site
London, NW10 7EW
GSK Investigational Site
London, W12 ONN
About this study
Official title: An Open Label Positron Emission Tomography Study in Healthy Male Subjects to Investigate Brain PDE4 Engagement, Pharmacokinetics and Safety of Single Oral Doses of GSK356278, Using 11C-(R)-Rolipram as a PET Ligand(s)
This study will investigate if a new experimental drug to treat Huntington's Disease gets into the brain. If it does get into the brain the study will explore the relationship between the amount of drug in the brain and the amount of drug in the blood. The study will involve healthy male volunteers.
Read the detailed description
This is an open label, non-randomized, adaptive design PET occupancy study in healthy adult males. The primary aim of this study is to describe the relationship between plasma concentrations and brain PDE4 occupancy of GSK356278 over time. Up to 24 healthy volunteers may be administered single doses of GSK356278 in order to obtain 12 evaluable complete data sets of occupancy estimates. This study will help to optimize the dose selection for future clinical studies with GSK356278.
- Conditions
- Huntington Disease
- Being tested
- GSK356278, Rolipram
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK356278Drug
Investigational Medicinal Product
RolipramDrug
Challenge Agent
| Study group | Role | What they receive |
|---|---|---|
| GSK356278 | Experimental | Investigational drug Receives: Drug: GSK356278; Drug: Rolipram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positron Gamma-ray emmision & voxel counts
Brain regions of interest and associated radionuclitide-activity
Measured: 60 minutes
systemic plasma concentration
serial sampling: GSK356278 concentration expressed as mass per unit of volume
Measured: 24 hours
Secondary outcomes (3)
Blood pressure - mm/Hg
Standard clinical pharmacology safety monitoring of vital signs
Measured: 24 hours
ECG - 12-Lead & Telemetry
Standard clinical pharmacology safety monitoring
Measured: 24 & 72 hours
Heart rate - bpm
Standard clinical pharmacology safety monitoring of vital signs
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2012 (estimated)
- Study start22 Nov 2011
- Primary completion12 Apr 2012
- Study completion12 Apr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT01602900
- Sponsor's protocol ID
- 116038
- Status last verified
- Jun 2017
- First submitted
- 1 Dec 2011
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Positron Emission Tomography Study in Healthy Male Subjects to Investigate Brain PDE4 Engagement, Pharmacokinetics and Safety of Single Oral Doses of GSK356278, Using 11C-(R)-Rolipram as a PET Ligand(s)
- ClinicalTrials.gov ID
- NCT01602900
- Acronym / sponsor ID
- 116038
- Conditions
- Huntington Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2011 (actual)
- Primary completion
- 12 Apr 2012 (actual)
- Study completion
- 12 Apr 2012 (actual)
- First posted
- 21 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate if a new experimental drug to treat Huntington's Disease gets into the brain. If it does get into the brain the study will explore the relationship between the amount of drug in the brain and the amount of drug in the blood. The study will involve healthy male volunteers.
Detailed description
This is an open label, non-randomized, adaptive design PET occupancy study in healthy adult males. The primary aim of this study is to describe the relationship between plasma concentrations and brain PDE4 occupancy of GSK356278 over time. Up to 24 healthy volunteers may be administered single doses of GSK356278 in order to obtain 12 evaluable complete data sets of occupancy estimates. This study will help to optimize the dose selection for future clinical studies with GSK356278.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GSK356278 | Experimental | Drug: GSK356278, Drug: RolipramInvestigational drug |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male volunteer, aged 22-55 years.
- Normal blood pressure, laboratory values, and body mass index
- Willing to agree to study procedures \& contraception requirements
- Capable of giving written informed consent
Key exclusion criteria (5 listed)
- Any evidence of disease that would preclude participation in the clinical study (includes sexually transmitted diseases, exessive alcohol consumption, and substance abuse).
- Previously involved in another clinical trial within 3 months prior to scheduled administration of study drug
- Smoker
- Suffers from claustrophobia
- Any contraindications for MRI scanning (e.g. pacemaker, metal implants or fillings)
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 |
|---|---|---|
| GSK356278Investigational Medicinal Product | Drug | GSK356278 |
| RolipramChallenge Agent | Drug | GSK356278 |
Primary outcome
Positron Gamma-ray emmision & voxel counts
Time frame: 60 minutes
Brain regions of interest and associated radionuclitide-activity
systemic plasma concentration
Time frame: 24 hours
serial sampling: GSK356278 concentration expressed as mass per unit of volume
3 secondary outcomes
Blood pressure - mm/Hg
Time frame: 24 hours
ECG - 12-Lead & Telemetry
Time frame: 24 & 72 hours
Heart rate - bpm
Time frame: 72 hours
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 20 Jun 2017.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study 116038 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK356278 and Rolipram in people with Huntington Disease, run by GlaxoSmithKline at 2 sites 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 4 inclusion and 5 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 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Positron Gamma-ray emmision & voxel counts (time frame: 60 minutes). The study lists 2 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 20 Jun 2017.