Bipolar DepressionPhase 1NCT00908154
Safety, Tolerability and Pharmacokinetics of Repeat Doses of GSK1014802.
A Phase 1 study testing GSK1014802 in people with Bipolar Depression and Bipolar Disorder, run by Biogen at 1 site in United Kingdom.
Trial summary
GSK1014802 is a use-dependent sodium channel blocker and an effective anticonvulsant in animal models. This study is being conducted to obtain information regarding the safety, tolerability and pharmacokinetics of repeated doses of GSK1014802 administered for up to 28 days in healthy male or female subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Depression, Bipolar Disorder
- What is being tested?
- GSK1014802
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 May 2008to 31 Dec 2008
- 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
- Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Male or female (of non-child bearing potential) subjects aged between 18 and 55 years.
- A female subject is eligible to participate if she is of non-childbearing potential.
- Male subjects must agree to use an acceptable form of contraception.
- Body weight ≥ 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive)
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
Who cannot join
- The subject has a positive pre-study drug/alcohol screen.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females).
- Current or past history of symptomatic orthostatic hypotension or history of unexplained vasovagal episode(s).
- 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 (60 h) or twice the duration of the biological effect of the investigational product (whichever is longer).
Show all 17Show fewer
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- 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.
- 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 GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Pregnant females.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- . Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
- History of known or suspected seizures, including infantile febrile, unexplained significant and recent loss of consciousness or history of significant head trauma with loss of consciousness or a family history (first degree relative) of epilepsy or seizures (fits).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeat Doses of GSK1014802 and Its Interaction With Food in Healthy Volunteers
GSK1014802 is a use-dependent sodium channel blocker and an effective anticonvulsant in animal models.
This study is being conducted to obtain information regarding the safety, tolerability and pharmacokinetics of repeated doses of GSK1014802 administered for up to 28 days in healthy male or female subjects. In addition, the effect of food on the pharmacokinetics of GSK1014802 will be investigated.
Read the detailed description
This study, previously posted by GlaxoSmithKline (GSK), was transitioned to Convergence Pharmaceuticals, Ltd., which spun off from GSK. Convergence Pharmaceuticals, Ltd., has now been acquired by Biogen.
- Conditions
- Bipolar Depression, Bipolar Disorder
- Being tested
- Placebo, GSK1014802
- Keywords
- sodium channel blocker, bipolar disorder, repeat dose
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Tablets to match GSK1014802
GSK1014802Drug
Also called BIIB074 and CNV1014802
Sodium channel blocker
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | Not described Receives: Drug: Placebo; Drug: GSK1014802 |
| Cohort 4 | Other | Not described Receives: Drug: Placebo; Drug: GSK1014802 |
| Cohort 3 | Other | Not described Receives: Drug: Placebo; Drug: GSK1014802 |
| Cohort 2 | Other | Not described Receives: Drug: Placebo; Drug: GSK1014802 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability will be evaluated by monitoring AEs and concomitant medication, ECG, Lead II monitoring, Holter monitoring, vital signs, and laboratory parameters.
Measured: 14-28 days
Blood concentrations of GSK1014802 following a single oral dose of GSK1014802.
Measured: 1 day
Blood concentrations of GSK1014802 following repeated oral doses of GSK1014802 given once daily or twice daily and their relationship with the GSK1014802 exposure after a single dose.
Measured: 14-28 days
Blood concentrations of GSK1014802 following repeated oral doses of GSK1014802 given once daily with or without food.
Measured: 14-28 days
Secondary outcomes (1)
Bond-Lader VAS scale
Measured: 14-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study start31 May 2008
- Primary completion31 Dec 2008
- Study completion31 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DepressionStudies of the same condition, open and under way.
- More trials run by BiogenThe 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Biogen Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908154
- Sponsor's protocol ID
- 107727
- Other IDs
- SCB107727
- Status last verified
- Oct 2017
- First submitted
- 7 May 2009
- Last updated
- 30 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeat Doses of GSK1014802 and Its Interaction With Food in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00908154
- Acronym / sponsor ID
- 107727
- Conditions
- Bipolar Depression, Bipolar Disorder
- Keywords
- sodium channel blocker, bipolar disorder, repeat dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 31 May 2008 (actual)
- Primary completion
- 31 Dec 2008 (actual)
- Study completion
- 31 Dec 2008 (actual)
- First posted
- 25 May 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.
GSK1014802 is a use-dependent sodium channel blocker and an effective anticonvulsant in animal models.
This study is being conducted to obtain information regarding the safety, tolerability and pharmacokinetics of repeated doses of GSK1014802 administered for up to 28 days in healthy male or female subjects. In addition, the effect of food on the pharmacokinetics of GSK1014802 will be investigated.
Detailed description
This study, previously posted by GlaxoSmithKline (GSK), was transitioned to Convergence Pharmaceuticals, Ltd., which spun off from GSK. Convergence Pharmaceuticals, Ltd., has now been acquired by Biogen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Drug: Placebo, Drug: GSK1014802 |
| Cohort 4 | Other | Drug: Placebo, Drug: GSK1014802 |
| Cohort 3 | Other | Drug: Placebo, Drug: GSK1014802 |
| Cohort 2 | Other | Drug: Placebo, Drug: GSK1014802 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
Key exclusion criteria (17 listed)
- The subject has a positive pre-study drug/alcohol screen.
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 |
|---|---|---|
| PlaceboTablets to match GSK1014802 | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| GSK1014802Also: BIIB074 and CNV1014802Sodium channel blocker | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Safety and tolerability will be evaluated by monitoring AEs and concomitant medication, ECG, Lead II monitoring, Holter monitoring, vital signs, and laboratory parameters.
Time frame: 14-28 days
Blood concentrations of GSK1014802 following a single oral dose of GSK1014802.
Time frame: 1 day
Blood concentrations of GSK1014802 following repeated oral doses of GSK1014802 given once daily or twice daily and their relationship with the GSK1014802 exposure after a single dose.
Time frame: 14-28 days
Blood concentrations of GSK1014802 following repeated oral doses of GSK1014802 given once daily with or without food.
Time frame: 14-28 days
1 secondary outcome
Bond-Lader VAS scale
Time frame: 14-28 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 30 Oct 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.
Biogen Medical Director study director
Biogen
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 GSK1014802 in people with Bipolar Depression and Bipolar Disorder, run by Biogen 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 7 inclusion and 17 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 30 Oct 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 will be evaluated by monitoring AEs and concomitant medication, ECG, Lead II monitoring, Holter monitoring, vital signs, and laboratory parameters. (time frame: 14-28 days). The study lists 4 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 30 Oct 2017.