A randomized, double-blind, placebo-controlled, three-period two treatment incomplete-block crossover study to investigate the effects of intravenous GSK3858279 on a battery of evoked pain tests in healthy participants.
- Conditions
- Chronic pain diseasesChronic pain diseases.
- Registration Number
- NL-OMON55004
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Participant must be 18 to 50 years of age inclusive, at the time of signing
the informed consent.
2. Participants who are overtly healthy as determined by medical evaluation
including medical history, physical examination, laboratory tests, vital signs
and cardiac monitoring.
3. Body weight within 50*100 kg and body mass index (BMI) within the range
18---30 kg/m2 (inclusive).
4. Must be Male:
Participants must agree to the following during the intervention period and for
at least 90 days after the last dose of study intervention:
- Refrain from donating sperm.
PLUS, either:
-Be abstinent from heterosexual intercourse as their preferred and usual
lifestyle
OR:
- Must agree to use contraception/barrier as detailed below:
- Agree to use a male condom
-And should also be advised of the benefit for a female partner to use a highly
effective method of contraception.
5. Capable of giving signed informed consent as described in Appendix 1 of the
protocol which includes compliance with the requirements and restrictions
listed in the informed consent form (ICF) and in this protocol.
1. History or presence of/significant history of or current cardiovascular,
respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or
neurological disorders capable of significantly altering the absorption,
metabolism, or elimination of drugs; constituting a risk when taking the study
intervention or interfering with the interpretation of data
2. Personal or family history of cardiomyopathy.
3. Abnormal blood pressure as determined by the investigator.
4. Symptomatic herpes zoster within 3 months prior to screening.
5. Evidence of active or latent tuberculosis (TB) as documented by medical
history andvexamination, and TB testing: a positive (not indeterminate)
QuantiFERON-TB Gold test.
6. Significant allergies to humanized monoclonal antibodies.
7. Clinically significant multiple or severe drug allergies, intolerance to
topical corticosteroids, or severe post-treatment hypersensitivity reactions
(including, but not limited to, erythema multiforme major, linear
immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative
dermatitis)
8. Lymphoma, leukaemia, or any malignancy. Those who are at risk of DNA repair
diseases or any family history of DNA repair disease.
9. Alanine transaminase (ALT) >1.5x upper limit of normal (ULN).
10. Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if
bilirubin is fractionated and direct bilirubin <35%).
11. Current or chronic history of liver disease or known hepatic or biliary
abnormalities (with the exception of Gilbert's syndrome or asymptomatic
gallstones).
12. QTc >450 msec
NOTES:
-The QTc is the QT interval corrected for heart rate according to Bazett*s
formula (QTcB), Fridericia*s formula (QTcF), and/or another method, machineread
or manually over-read.
- The specific formula that will be used to determine eligibility and
discontinuation for an individual subject will be QTcF. In other words, several
different formulae cannot be used to calculate the QTc for an individual subject
and then the lowest QTc value used to include or discontinue the subject from
the trial.
-For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a
composite of available values of QTc will be used as specified in the Reporting
and Analysis Plan (RAP).
13. History of Stevens-Johnson Syndrome.
14. Known immunodeficiency.
15. Participants with an acute, re-current or chronic infection (e.g.,
osteomyelitis), who have been receiving treatment within three months prior to
dosing or individuals with an active infection.
16. Previous or current history of excessive bleeding or coagulation disorders.
17. Previous history of hypertrophic or keloid scarring.
18. Any current, clinically significant, known medical condition in particular
any existing conditions that would affect sensitivity to cold (such as
atherosclerosis, Raynaud*s disease, urticaria, hypothyroidism) or pain (such as
disease that causes pain, hypesthesia, hyperalgesia, allodynia, paraesthesia,
neuropathy).
19. Participants indicating pain tests intolerable at screening. Participants
achieving tolerance at >80% of maximum input intensity for cold pressor and
electrical pain tests are to be excluded. If pressure pain test tolerance is
>80% of maximum input intensity they may be enrolled as per PI judgement
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- UVB heat pain detection (oC)<br /><br>- Cold pressor time to intolerable pain threshold (secs)<br /><br>- Electrical pain tolerance threshold (mA) - single stimulus</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA </p><br>