A First Time in Human Study of GSK586529 in Healthy Volunteers
NCT00703547 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2017-08-22
Summary
A single blind, randomized, placebo-controlled, crossover study in twenty four healthy male subjects. Subjects will be divided into two cohorts with alternate panel design. The study is investigating the safety, tolerability and pharmacokinetics of single oral escalating doses of GSK586529.
Conditions
- Depressive Disorder and Anxiety Disorders
Interventions
- DRUG
-
GSK586529 capsules
GSK586529 will be provided as white gelatin capsule with a dose of 3 milligrams.
- DRUG
-
GSK586529 tablets
GSK586529 will be provided as a yellow film-coated tablets for oral administration at three different strengths 10 milligrams, 60 milligrams and 120 milligrams.
- DRUG
-
Placebo tablets and capsules will be provided to subjects.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-01-28
- Primary Completion
- 2008-04-11
- Completion
- 2008-04-11
Countries
- United Kingdom
Study Locations
More Related Trials
-
Relative Bioavailability and Food Effect Study for GSK163090 in Healthy Male and Female Volunteers
NCT00536679 ·Status: COMPLETED ·Phase: PHASE1
-
Patient Tolerability Study of GSK163090
NCT00559299 ·Status: COMPLETED ·Phase: PHASE1
-
GSK372475 Bioequivalence Study
NCT00488098 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)
NCT05203341 ·Status: COMPLETED ·Phase: PHASE2
-
Multiple Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY03005
NCT02271412 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Pharmacokinetics and Pharmacodynamics Study of BMS-866949 in Healthy Subjects
NCT00949767 ·Status: COMPLETED ·Phase: PHASE1
-
This is a Study to Determine the Antidepressant Effects of AZD6765
NCT00986479 ·Status: COMPLETED ·Phase: PHASE2
-
TAK-653 Escalating Single and Multiple Dose Study in Healthy Participants
NCT02561156 ·Status: COMPLETED ·Phase: PHASE1
-
AZD6765 for Treatment Resistant Depression
NCT00491686 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Effectiveness Study of BCI-540 Versus Placebo in the Treatment of Major Depressive Disorder With Concomitant Anxiety
NCT00621270 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Antidepressant Efficacy of a Selective, High Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder (AMDD)
NCT00759395 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetics, Effect of Food, Safety and Tolerability of a New Tablet Formulation of GSK1144814 in Healthy Subjects
NCT01090440 ·Status: COMPLETED ·Phase: PHASE1
-
BPL-003 Efficacy and Safety in Treatment Resistant Depression
NCT05870540 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder
NCT00252330 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Bipolar Depression
NCT03965871 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder
NCT00252356 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Depression
NCT03965858 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.
NCT01288079 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Test Different Doses of BI 1569912 in People With Depression
NCT06558344 ·Status: COMPLETED ·Phase: PHASE2
-
Study of BMS-562086 in the Treatment of Outpatients With Major Depressive Disorder
NCT00135421 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
The Safety, Tolerability, and Pharmacokinetics Study of HEC113995 PA•H2O Tablets in Healthy Subjects
NCT04591301 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial of GH001 in Patients With Treatment-resistant Depression
NCT05800860 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression
NCT04599855 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder
NCT06267846 ·Status: COMPLETED ·Phase: PHASE2
-
"A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder"
NCT06564818 ·Status: RECRUITING ·Phase: PHASE3