GSK2018682 FTIH in Healthy Volunteers

NCT01387217 | Completed Phase 1

• 1 other identifier: 114070
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

This protocol describes the first administration of GSK2018682 to humans. The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of GSK2018682. The study will also provide preliminary evidence of the potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on total lymphocyte counts.

Conditions

Multiple Sclerosis

Keywords

GSK2018682; First Time in Human; Healthy Volunteer

Outcome Measures

Primary Outcomes (4)

• To investigate the safety and tolerability of single escalating oral doses of GSK2018682

  Adverse event and safety lab monitoring

  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

  12 lead ECG and telemetry monitoring plus vital signs (systolic and diastolic blood blood pressures), heart rate, respiratory rate and temperature

  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 pharmacokinetics of single doses of GSK2018682

  Peak blood concentration, time of peak blood concentration, oral clearance, half life and AUC

  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)

  Reduction from baseline in lymphocyte counts obtained at different time points after dosing and at different dose levels

  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

Study Arms (2)

Part A

EXPERIMENTAL

Part A will be used to confirm the prediction of GSK2018682 PK, assess its effects on lymphocytes, and monitor its safety profile in a single cohort (Cohort 1). Cohort 1 will consist of 4 subjects and explore 4 doses of GSK2018682 in 4 study sessions. In each session, three subjects will receive GSK2018682 and one subject will receive placebo. Thus, when the cohort completes, each subject will receive placebo and 3 doses of GSK2018682.

Drug: GSK2018682; Drug: Placebo

Part B

EXPERIMENTAL

Part B will explore doses to refine the dose-response curve of GSK2018682 on lymphocyte suppression, as allowed by stopping criteria, in 1 or 2 cohorts of up to 15 subjects (Cohort 2 and Cohort 3). In Part B, up to six single ascending doses of GSK2018682 and one dose of placebo will be investigated in up to 8 sessions.

Drug: GSK2018682; Drug: Placebo

Interventions

GSK2018682 DRUG

GSK2018682

Part A; Part B

Placebo DRUG

Matched Placebo

Part A; Part B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Randwick, New South Wales, 2031, Australia

Location

GSK Investigational Site

Adelaide, South Australia, 5000, Australia

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study 114070 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

GSK2018682

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: July 4, 2011
• Study Start: May 21, 2010
• Primary Completion: December 20, 2010
• Study Completion: December 20, 2010
• Last Updated: June 9, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

AU (2)