NL-OMON55004
Completed
Not Applicable
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. - GSK3858279 vs PBO, Phase 1, Pain Tests, PK and Target Engagement in HV
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic pain diseases.
- Sponsor
- GlaxoSmithKline
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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