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Pain, NeuropathicPhase 1NCT00964288

Effect of GSK1014802 on Electrical Hyperalgesia and Threshold Tracking in Healthy Subjects

A Phase 1 study testing GSK1014802 low dose, Lidocaine and GSK1014802 high dose in people with Pain, Neuropathic and Neuropathic Pain, run by Biogen.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is being conducted to assess the effects of GSK1014802 and a positive control, lidocaine, on tests of peripheral nerve excitability. This will be a double blind, placebo controlled, 4-period cross over study. 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
Pain, Neuropathic, Neuropathic Pain
What is being tested?
GSK1014802 low dose, Lidocaine and GSK1014802 high dose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
No sites listed yet
Study dates
31 Jul 2009to 30 Nov 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 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male between 18 and 55 years of age inclusive.
  • AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN
  • Healthy as determined by a responsible and experienced physician.
  • Male subjects must agree to use one of the contraception methods requested.
  • Body weight greater than or equal to 50 kg, BMI ≤29.9kg/m2
  • Capable of giving written informed consent.
  • QTcB or QTcF < 450 msec.

Who cannot join

  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result.
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • A positive pre-study drug/alcohol screen.
  • A positive test for HIV antibody.
  • Heart block, bundle branch block, hemi-block, evidence of accessory cardiac conduction pathways, long pauses >2 s or other cardiac conduction abnormalities or cardiac arrhythmias on 12-lead ECG or 24 h Holter at screening.
  • History of regular excessive alcohol consumption within 6 months of the study.
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  • The subject has participated in a clinical trial and has received an investigational product within 90 days o fthe strat of this study.
  • 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.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • Subject is mentally or legally incapacitated.
  • Subjects with a 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.
  • Average daily caffeine intake equivalent to > 4 cups of coffee or > 6 cups of tea.
  • Current or past history of symptomatic orthostatic hypotension or history of vasovagal episode(s).
  • Subjects with systolic blood pressure persistently above 140 mmHg and/or diastolic blood pressure persistently above 90 mmHg.
  • 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).
  • The subject has a history of chronic pain before screening.
  • The subject has used any topical steroid in the previous 30 days if, in the opinion of the investigator this is likely to interfere with study assessments.
  • The subject has used any topical capsaicin preparations on the forearms in the previous 30 days.
  • The subject suffers from eczema, psoriasis or any other acute or chronic dermatological problem if, in the opinion of the investigator this is likely to interfere with study assessments
  • The subject suffers from tinnitus, or has done in the past 3 months.
  • Suffers from skin infection or inflammation of the forearm, or has other arm skin irregularities that may in the opinion of the investigator interfere with study assessments.
  • Needle phobic.
  • The subject does not produce an area of allodynia or hyperalgesia to the electrical hyperalgesia model during the screening session.
  • The subject is unable to tolerate the electrical hyperalgesia model or threshold tracking, including anxiety or atypical response to the stimulation.
  • Any history of suicidal behaviour or any suicidal ideation of type 4 or 5 on the C-SSRS in the last month.
  • Poor veins that would be estimated not to be suitable by a physician for repeated cannulation in both arms.

About this study

Official title: A Double Blind, Double Dummy, Placebo Controlled Cross Over Study With a Positive Control to Investigate the Effect of a GSK Drug on Electrical Hyperalgesia and Threshold Tracking in Healthy Subjects

This study is being conducted to assess the effects of GSK1014802 and a positive control, lidocaine, on tests of peripheral nerve excitability. This will be a double blind, placebo controlled, 4-period cross over study. Approximately 20 subjects will be randomised to one of two doses of a GSK1014802, lidocaine and placebo with at least 2 weeks between sessions. A follow-up will occur 7-15 days after the last dose.

During treatment session 3 on the 6th October 2009, one subject had a pattern of AEs of severe intensity, suggestive of brain stem toxicity / encephalopathy during the lidocaine/saline infusion period. Although recognised in the literature when lidocaine was used in patients for treatment of pain, these AEs were unusual in studies in healthy subjects. The study was suspended to allow re-evaluation of the risk:benefit balance of lidocaine/saline infusion in healthy subjects in this study. It was decided that continuation of the use of lidocaine (positive control) would risk the safety of subjects. Continuation without the positive control was not possible as it would compromise the scientific integrity of the design.

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.

Being tested
GSK1014802 low dose, Lidocaine, GSK1014802 high dose, Placebo
Keywords
electrical hyperalgesia, threshold tracking, pain
Medical subject headings
Neuralgia, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK1014802 low doseDrug

    Also called BIIB074 and CNV1014802

    oral tablet

  • LidocaineDrug

    positive control

  • GSK1014802 high doseDrug

    Also called BIIB074 and CNV1014802

    oral tablet

  • PlaceboDrug

    To match GSK drug and positive control

Study groups in NCT00964288
Study groupRoleWhat they receive
Period 1OtherNot described
Receives: Drug: GSK1014802 low dose; Drug: Lidocaine; Drug: GSK1014802 high dose; Drug: Placebo
Period 2OtherNot described
Receives: Drug: GSK1014802 low dose; Drug: Lidocaine; Drug: GSK1014802 high dose; Drug: Placebo
Period 3OtherNot described
Receives: Drug: GSK1014802 low dose; Drug: Lidocaine; Drug: GSK1014802 high dose; Drug: Placebo
Period 4OtherNot described
Receives: Drug: GSK1014802 low dose; Drug: Lidocaine; Drug: GSK1014802 high dose; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the effect of single oral doses of GSK1014802 on area of flare evoked by cutaneous electrical stimulation.

    Measured: 16 weeks

Secondary outcomes (3)

  1. To determine the effect of single oral doses of GSK1014802 and a single i.v. infusion of lidocaine on tests of nerve excitability

    Measured: 16 weeks

  2. To further investigate the safety and tolerability of single oral doses of GSK1014802

    Measured: 16 weeks

  3. To assess relationships between GSK1014802 pharmacokinetics and pharmacodynamic endpoints.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2009 (estimated)
  2. Study start31 Jul 2009
  3. Primary completion30 Nov 2009
  4. Study completion30 Nov 2009

Why it stopped: During treatment session 3, a subject had a pattern of AEs of severe intensity, suggestive of brainstem toxicity/encephalopathy during lidocaine/saline infusion

Resources

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
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00964288
Sponsor's protocol ID
111676
Other IDs
NP111676
Status last verified
Oct 2017
First submitted
23 Jul 2009
Last updated
26 Oct 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK1014802 low dose, Lidocaine and GSK1014802 high dose in people with Pain, Neuropathic and Neuropathic Pain, run by Biogen.

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 30 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: stopped early, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

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 was stopped early (reason given: During treatment session 3, a subject had a pattern of AEs of severe intensity, suggestive of brainstem toxicity/encephalopathy during lidocaine/saline infusion). Results are not available in the source record.

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?

To determine the effect of single oral doses of GSK1014802 on area of flare evoked by cutaneous electrical stimulation. (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00964288.

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 26 Oct 2017.

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