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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35301

Enrollment

Registered

2011-11-08

Start date

2011-12-10

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ziekte van Huntington Genetic disorder that affects the muscle coordination Huntington's disease

Interventions

Study Medication Active substance: GSK356278 Activity :PDE4 inhibitor Indication: Huntington*s disease Strength: 0.5 * 14 mg Dosage form: Oral tablet Treatments Cohort 1: a repeated dose of 2 mg GS

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)