A Randomised, Placebo Controlled, Ascending, Repeat Dose Study in Healthy Volunteers Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK356278

Completed

• Conditions: Ziekte van Huntington; Genetic disorder that affects the muscle coordination; Huntington's disease

• Registration Number: NL-OMON35301
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

- Healthy male and female volunteers
- Age between 18 - 65 years
- BMI between 19.0 - 30.0 kg/m2
- Only non-smokers

Exclusion Criteria

Suffering from: Hepatitis B or C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 90 days from the start of the study of in case of donating more than 1.5 liters of blood (for men) or more than 1.0 liters of blood (for women) in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacodynamics :EEG, cognitive tests, BNDF<br /><br>Pharmacokinetics: Plasma GSK356278 concentrations, pharamkinetic parameters<br /><br>Safety: adverse events, vital signs, ECG-parameters, telemetry ECG-parameters,<br /><br>laboratory parameters, physical examination, Rhodes index of nausea, vomiting &<br /><br>retching (INVR), self-rated alertness using bond and lader visual analogue<br /><br>scales (VAS)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n/a</p><br>