GSK2018682 FTIH in Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01387217
• Date of registration: 14/04/2011
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: GSK2018682 FTIH in Healthy Volunteers P1A114070
• Scientific title: A Single-blind, Placebo-controlled, Two Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of GSK2018682 in Healthy Volunteers
• Date of first enrolment: May 21, 2010
• Target sample size: 27
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01387217
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: Phase 1

Countries of recruitment

Australia

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy as determined by a responsible and experienced physician, based on a medical
evaluation including medical history, physical examination, laboratory tests and
cardiac monitoring. A subject with a clinical abnormality or laboratory parameters
significantly outside the reference range for the population being studied may be
included only if the Investigator and the GSK Medical Monitor agree that the finding
is unlikely to introduce additional risk factors and will not interfere with the study
procedures. Subjects with lymphocyte counts outside the normal range should always be
excluded from enrollment

- BMI within the range 19 - 28 kg/m2 (inclusive).

Exclusion Criteria:

- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
result within 3 months of screening

- 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.

- History of regular alcohol consumption

- Subjects with a history of, or examination suspicious for, skin cancer(s) including
melanoma, basal cell or squamous cell carcinoma.

- Systolic blood pressure less than 95 mmHg or greater than 140 mmHg, or diastolic blood
pressure less than or equal to 50 mmHg or greater than or equal to 95 mmHg.

- Symptomatic reduction in blood pressure after orthostatic challenge.

- Subjects with resting heart rate less than 45 beats per minute or greater than 90
beats per minute

Other criteria may apply as defined by the clinical protocol.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Placebo

Drug: GSK2018682

Primary Outcome(s)

To investigate the pharmacokinetics of single doses of GSK2018682 [Time Frame: Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks]

Evaluate the effect of single escalating oral doses of GSK2018682 on lymphocytes (totals plus subsets) [Time Frame: Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks]

To investigate effects of GSK2018682 on heart rate and blood pressure [Time Frame: Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks]

To investigate the safety and tolerability of single escalating oral doses of GSK2018682 [Time Frame: Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks]

Secondary ID(s)

114070

Source(s) of Monetary Support

Please refer to primary and secondary sponsors