Cognitive DisordersPhase 1NCT00950586
Safety, Blood Levels, Drug Interaction and Effects of Repeated Doses of GSK1034702
A Phase 1 study testing GSK1043702 and Dextromethorphan in people with Cognitive Disorders, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
GSK1034702 is being developed for improving cognitive impairment in diseases such as Alzheimer's disease and schizophrenia. This study will be done in healthy men and women of no child beading potential to investigate repeated doses of the study medicine. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Disorders
- What is being tested?
- GSK1043702 and Dextromethorphan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Aug 2009to 24 Dec 2009
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female of non childbearing potential
- Generally healthy
- Body mass index 19 - 29.9 kg/m2 (inclusive), body weight greater than or equal to 50 kg for males and greater than of equal to 45 kg for females
- Normal Laboratory test results
Who cannot join
- Abuse of drugs or alcohol
- Smoker or history of regular use of tobacco- or nicotine-containing products in the past 6 months
- ECG abnormality (personal or family history)
- Psychiatric disorder
- Asthma or a history of asthma
- Medical illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-controlled, Single-blind, Randomised Study to Investigate the Safety, Tolerability, Pharmacokinetics and Drug Interaction of GSK1034702 After Repeat Doses in Healthy Subjects
GSK1034702 is being developed for improving cognitive impairment in diseases such as Alzheimer's disease and schizophrenia. This study will be done in healthy men and women of no child beading potential to investigate repeated doses of the study medicine. The study will investigate the following questions, do repeated doses of the study medicine have any important side effects when taken by mouth? How much of the study medicine gets into the bloodstream, and how quickly does the body get rid of it? Does the study medicine affect memory, attention and problem-solving skills? What are the effects when the study medicine and dextromethorphan are taken together.
- Conditions
- Cognitive Disorders
- Being tested
- GSK1043702, Dextromethorphan, Placebo
- Keywords
- Drug interaction, Saftey, Pharmacokinetics, Cognition
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1043702Drug
Oral dose in liquid or tablet formulation
DextromethorphanDrug
30mg Oral dose
PlaceboDrug
To match GSK1034702
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 14 days dosing Receives: Drug: GSK1043702; Drug: Placebo |
| Cohort 2 | Experimental | Single dose followed by 14 days repeat dosing Receives: Drug: GSK1043702; Drug: Placebo |
| Cohort 3 | Experimental | Up to 28 days repeat dosing with drug interaction Receives: Drug: GSK1043702; Drug: Dextromethorphan; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability endpoints consisting of: AEs; 12-lead ECG; 12 lead digital Holter and lead II telemetry; vital signs; clinical laboratory evaluations.
Measured: Up to 28 days
GSK1034702 PK parameters: Cmax; tmax; AUC(0-t)
Measured: Up to 28 days
Dextromethorphan PK parameters: Cmax; tmax; AUC(0-t).
Measured: Day -2, 1 and 14
Effects on Cognitive tests.
Measured: Up to day 28
Effects on salivary secretion
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2009 (estimated)
- Study start24 Aug 2009
- Primary completion24 Dec 2009
- Study completion24 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DisordersStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 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
- NCT00950586
- Sponsor's protocol ID
- 110792
- Status last verified
- Jul 2017
- First submitted
- 30 Jul 2009
- Last updated
- 13 Jul 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 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Single-blind, Randomised Study to Investigate the Safety, Tolerability, Pharmacokinetics and Drug Interaction of GSK1034702 After Repeat Doses in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00950586
- Acronym / sponsor ID
- 110792
- Conditions
- Cognitive Disorders
- Keywords
- Drug interaction, Saftey, Pharmacokinetics, Cognition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2009 (actual)
- Primary completion
- 24 Dec 2009 (actual)
- Study completion
- 24 Dec 2009 (actual)
- First posted
- 3 Aug 2009 (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.
GSK1034702 is being developed for improving cognitive impairment in diseases such as Alzheimer's disease and schizophrenia. This study will be done in healthy men and women of no child beading potential to investigate repeated doses of the study medicine. The study will investigate the following questions, do repeated doses of the study medicine have any important side effects when taken by mouth? How much of the study medicine gets into the bloodstream, and how quickly does the body get rid of it? Does the study medicine affect memory, attention and problem-solving skills? What are the effects when the study medicine and dextromethorphan are taken together.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: GSK1043702, Drug: Placebo14 days dosing |
| Cohort 2 | Experimental | Drug: GSK1043702, Drug: PlaceboSingle dose followed by 14 days repeat dosing |
| Cohort 3 | Experimental | Drug: GSK1043702, Drug: Dextromethorphan, Drug: PlaceboUp to 28 days repeat dosing with drug interaction |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female of non childbearing potential
- Generally healthy
- Body mass index 19 - 29.9 kg/m2 (inclusive), body weight greater than or equal to 50 kg for males and greater than of equal to 45 kg for females
- Normal Laboratory test results
Key exclusion criteria (6 listed)
- Abuse of drugs or alcohol
- Smoker or history of regular use of tobacco- or nicotine-containing products in the past 6 months
- ECG abnormality (personal or family history)
- Psychiatric disorder
- Asthma or a history of asthma
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 |
|---|---|---|
| GSK1043702Oral dose in liquid or tablet formulation | Drug | Cohort 1, Cohort 2, Cohort 3 |
| Dextromethorphan30mg Oral dose | Drug | Cohort 3 |
| PlaceboTo match GSK1034702 | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Safety and tolerability endpoints consisting of: AEs; 12-lead ECG; 12 lead digital Holter and lead II telemetry; vital signs; clinical laboratory evaluations.
Time frame: Up to 28 days
GSK1034702 PK parameters: Cmax; tmax; AUC(0-t)
Time frame: Up to 28 days
Dextromethorphan PK parameters: Cmax; tmax; AUC(0-t).
Time frame: Day -2, 1 and 14
Effects on Cognitive tests.
Time frame: Up to day 28
Effects on salivary secretion
Time frame: up to 28 days
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 Jul 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 110792 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
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 GSK1043702 and Dextromethorphan in people with Cognitive Disorders, 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 4 inclusion and 6 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 Jul 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 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?
Safety and tolerability endpoints consisting of: AEs; 12-lead ECG; 12 lead digital Holter and lead II telemetry; vital signs; clinical laboratory evaluations. (time frame: Up to 28 days). The study lists 5 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 Jul 2017.