Description:

Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

Keywords:
Versions (4) ▾
  1. 7/14/19
  2. 8/4/19
  3. 4/10/21
  4. 9/20/21
Copyright Holder:
GlaxoSmithKline
Uploaded on:

September 20, 2021

DOI:
No DOI assigned. To request one please log in.
License:
Creative Commons BY 4.0
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Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957

Day 1 - Summary Holter; Summary Holter Abnormalities; Electronically Transferred Lab Data; Pharmacokinetics Blood; Urinalysis

Date of Visit
Summary Holter
Interpretation of Holter
Summary Holter Abnormalities
Holter Abnormalities
Electronically Transferred Lab Data - Dosing Date and Time
Electronically Transerred Lab Data - Pre-dose
Haematology sample not taken
Clinical Chemistry sample not taken
Serum Prolactin sample not taken
TSH sample not taken
Testosterone sample not taken
Electronically Transerred Lab Data - 1 Hour
1 Hour - Haematology sample not taken
1 Hour - Clinical Chemistry sample not taken
1 Hour - Serum Prolactin sample not taken
1 Hour - TSH sample not taken
1 Hour - Testosterone sample not taken
Electronically Transerred Lab Data - 2 Hour
2 Hour - Haematology sample not taken
2 Hour - Clinical Chemistry sample not taken
2 Hour - Serum Prolactin sample not taken
2 Hour - TSH sample not taken
2 Hour - Testosterone sample not taken
Electronically Transerred Lab Data - 4 Hour
4 Hour - Haematology sample not taken
4 Hour - Clinical Chemistry sample not taken
4 Hour - Serum Prolactin sample not taken
4 Hour - TSH sample not taken
4 Hour - Testosterone sample not taken
Electronically Transerred Lab Data - 8 Hour
8 Hour - Haematology sample not taken
8 Hour - Clinical Chemistry sample not taken
8 Hour - Serum Prolactin sample not taken
8 Hour - TSH sample not taken
8 Hour - Testosterone sample not taken
Electronically Transerred Lab Data - 24 Hour
24 Hour - Haematology sample not taken
24 Hour - Clinical Chemistry sample not taken
24 Hour - Serum Prolactin sample not taken
24 Hour - TSH sample not taken
24 Hour - Testosterone sample not taken
Electronically Transerred Lab Data - 36 Hour
36 Hour - Haematology sample not taken
36 Hour - Clinical Chemistry sample not taken
36 Hour - Serum Prolactin sample not taken
36 Hour - TSH sample not taken
36 Hour - Testosterone sample not taken
Electronically Transerred Lab Data - 48 Hour
48 Hour - Haematology sample not taken
48 Hour - Clinical Chemistry sample not taken
48 Hour - Serum Prolactin sample not taken
48 Hour - TSH sample not taken
48 Hour - Testosterone sample not taken
Electronically Transerred Lab Data - 72 Hour
72 Hour - Serum Prolactin sample not taken
Pharmacokinetics Blood
Pharmacokinetics Blood - Predose - Not Done
Pharmacokinetics Blood - Predose - Not required
Pharmacokinetics Blood - 0.5 Hour - Not Done
Pharmacokinetics Blood - 0.5 Hour - Not required
Pharmacokinetics Blood - 1 Hour - Not Done
Pharmacokinetics Blood - 1 Hour - Not required
Pharmacokinetics Blood - 2 Hour - Not Done
Pharmacokinetics Blood - 2 Hour - Not required
Pharmacokinetics Blood - 1.5 Hour - Not Done
Pharmacokinetics Blood - 1.5 Hour - Not required
Pharmacokinetics Blood - 3 Hour - Not Done
Pharmacokinetics Blood - 3 Hour - Not required
Pharmacokinetics Blood - 4 Hour - Not Done
Pharmacokinetics Blood - 4 Hour - Not required
Pharmacokinetics Blood - 8 Hour - Not Done
Pharmacokinetics Blood - 8 Hour - Not required
Pharmacokinetics Blood - 24 Hour - Not Done
Pharmacokinetics Blood - 24 Hour - Not required
Pharmacokinetics Blood - 36 Hour - Not Done
Pharmacokinetics Blood - 36 Hour - Not required
Pharmacokinetics Blood - 48 Hour - Not Done
Pharmacokinetics Blood - 48 Hour - Not required
Pharmacokinetics Blood - Extra Scheduled Samples Entry
Pharmacokinetics Blood - Extra Scheduled Samples - Not Done
Pharmacokinetics Blood - Extra Scheduled Samples - Not required
Urinalysis - Dosing Date and Time
Urinalysis Dipstick Details - Pre-Dose
Urinalysis Pre-Dose - Sample not taken
Urinalysis Pre-Dose - Dipstick - pH
Urinalysis Dipstick Pre-Dose - Specific Gravity
Urinalysis Dipstick Pre-Dose - Protein
Urinalysis Dipstick Pre-Dose - Glucose
Urinalysis Dipstick Pre-Dose - Ketones
Urinalysis Dipstick Pre-Dose - RBC
Urinalysis Dipstick Pre-Dose - WBC
Result of dipstick - Pre-Dose
Urinalysis Pre-Dose - If positive urine dipstick result, was sedimentary microscopy performed?
Urinalysis Dipstick Details - 2 Hour Post-Dose
Urinalysis 2 Hour Post-Dose - Sample not taken
Urinalysis 2 Hour Post-Dose - Dipstick - pH
Urinalysis Dipstick 2 Hour Post-Dose - Specific Gravity
Urinalysis Dipstick 2 Hour Post-Dose - Protein
Urinalysis Dipstick 2 Hour Post-Dose - Glucose
Urinalysis Dipstick 2 Hour Post-Dose - Ketones
Urinalysis Dipstick 2 Hour Post-Dose - RBC
Urinalysis Dipstick 2 Hour Post-Dose - WBC
Result of dipstick - 2 Hour Post-Dose
Urinalysis 2 Hour Post-Dose - If positive urine dipstick result, was sedimentary microscopy performed?
Urinalysis Dipstick Details - 4 Hour Post-Dose
Urinalysis 4 Hour Post-Dose - Sample not taken
Urinalysis 4 Hour Post-Dose - Dipstick - pH
Urinalysis Dipstick 4 Hour Post-Dose - Specific Gravity
Urinalysis Dipstick 4 Hour Post-Dose - Protein
Urinalysis Dipstick 4 Hour Post-Dose - Glucose
Urinalysis Dipstick 4 Hour Post-Dose - Ketones
Urinalysis Dipstick 4 Hour Post-Dose - RBC
Urinalysis Dipstick 4 Hour Post-Dose - WBC
Result of dipstick - 4 Hour Post-Dose
Urinalysis 4 Hour Post-Dose - If positive urine dipstick result, was sedimentary microscopy performed?
Urinalysis Dipstick Details - 8 Hour Post-Dose
Urinalysis 8 Hour Post-Dose - Sample not taken
Urinalysis 8 Hour Post-Dose - Dipstick - pH
Urinalysis Dipstick 8 Hour Post-Dose - Specific Gravity
Urinalysis Dipstick 8 Hour Post-Dose - Protein
Urinalysis Dipstick 8 Hour Post-Dose - Glucose
Urinalysis Dipstick 8 Hour Post-Dose - Ketones
Urinalysis Dipstick 8 Hour Post-Dose - RBC
Urinalysis Dipstick 8 Hour Post-Dose - WBC
Result of dipstick - 8 Hour Post-Dose
Urinalysis 8 Hour Post-Dose - If positive urine dipstick result, was sedimentary microscopy performed?
Urinalysis Dipstick Details - 24 Hour Post-Dose
Urinalysis 24 Hour Post-Dose - Sample not taken
Urinalysis 24 Hour Post-Dose - Dipstick - pH
Urinalysis Dipstick 24 Hour Post-Dose - Specific Gravity
Urinalysis Dipstick 24 Hour Post-Dose - Protein
Urinalysis Dipstick 24 Hour Post-Dose - Glucose
Urinalysis Dipstick 24 Hour Post-Dose - Ketones
Urinalysis Dipstick 24 Hour Post-Dose - RBC
Urinalysis Dipstick 24 Hour Post-Dose - WBC
Result of dipstick - 24 Hour Post-Dose
Urinalysis 24 Hour Post-Dose - If positive urine dipstick result, was sedimentary microscopy performed?
Urinalysis Dipstick Details - 36 Hour Post-Dose
Urinalysis 36 Hour Post-Dose - Sample not taken
Urinalysis 36 Hour Post-Dose - Dipstick - pH
Urinalysis Dipstick 36 Hour Post-Dose - Specific Gravity
Urinalysis Dipstick 36 Hour Post-Dose - Protein
Urinalysis Dipstick 36 Hour Post-Dose - Glucose
Urinalysis Dipstick 36 Hour Post-Dose - Ketones
Urinalysis Dipstick 36 Hour Post-Dose - RBC
Urinalysis Dipstick 36 Hour Post-Dose - WBC
Result of dipstick - 36 Hour Post-Dose
Urinalysis 36 Hour Post-Dose - If positive urine dipstick result, was sedimentary microscopy performed?
Urinalysis Dipstick Details - 48 Hour Post-Dose
Urinalysis 48 Hour Post-Dose - Sample not taken
Urinalysis 48 Hour Post-Dose - Dipstick - pH
Urinalysis Dipstick 48 Hour Post-Dose - Specific Gravity
Urinalysis Dipstick 48 Hour Post-Dose - Protein
Urinalysis Dipstick 48 Hour Post-Dose - Glucose
Urinalysis Dipstick 48 Hour Post-Dose - Ketones
Urinalysis Dipstick 48 Hour Post-Dose - RBC
Urinalysis Dipstick 48 Hour Post-Dose - WBC
Result of dipstick - 36 Hour Post-Dose
Urinalysis 36 Hour Post-Dose - If positive urine dipstick result, was sedimentary microscopy performed?
Urinalysis - Local: Microscopy Details
Urinalysis Microscopy - Red blood cells
Urinalysis Microscopy - White blood cells
Urinalysis Microscopy - Granular casts
Urinalysis Microscopy - Waxy casts

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