Last updated: 11/03/2018 11:12:30
A repeat dose study with GSK1018921 to assess safety, tolerability, pharmacokinetics, pharmacodynamics in healthy volunteers and patients with schizophrenia and to evaluate its effect on PK of midazolam.GT1110791
GSK study ID
110791
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: A 4-part parallel group, randomized, study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of repeat doses of GSK1018921 in healthy volunteers and stable patients with schizophrenia and to evaluate its effects on pharmacokinetics of midazolam.
Trial description: The purpose of this study is to understand safety and tolerability of the drug GSK1018921 after 14 days of dosing in healthy volunteers and then in patient volunteers.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Part A: Safety and tolerability endpoints consisting of: adverse events; 12-lead ECG; vital signs, clinical laboratory evaluations and PK parameters.
Timeframe: 14 days twice daily dosing.
Part B: Midazolam PK following single and repeat doses of GSK1018921.
Timeframe: 14 days twice daily dosing.
Part C: Plasma & CSF glycine concentrations following single doses og GSK1018921.
Timeframe: After single dosing.
Part D: Safety and tolerability endpoints consisting of: adverse events; 12-lead ECG; vital signs, clinical laboratory evaluations and movement scales Simpson Angus Scale, AIMS and Barnes akathisia Scale.
Timeframe: 28 days
Secondary outcomes:
Part A: Effects of GSK1018921 on VAS
Timeframe: 14 days.
Part B: None
Timeframe: 0
Part C: GSK1018921 plasma exposure-CSF glycine relationship
Timeframe: After single dosing.
Part D: Effects of GSK1018921 on VAS, PANSS and CGI
Timeframe: 28 days.
Interventions:
Enrollment:
34
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Schizophrenia
Product
GSK1018921
Collaborators
Not applicable
Study date(s)
July 2008 to November 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- All subjects (Healthy and Patients)
- Exclusion Criteria:
Inclusion and exclusion criteria
Inclusion criteria:
- All subjects (Healthy and Patients) Exclusion Criteria:
- History of drug or alcohol abuse.
- Consumption of drug, food or drink affecting the CYP450 metabolism pathway.
- Has received investigational drug within 30 days to 5 half lives or twice the duration of the biological effect of any drug (which ever is the longer).
- Donation of blood in excess of 500mL within a 56 day period. Patients eligibility
- Stable patients with schizophrenia.
Trial location(s)
Location
GSK Investigational Site
Bellaire, Texas, United States, 77401
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Glendale, California, United States, 91206
Status
Terminated/Withdrawn
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
2008-04-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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