Healthy Male Volunteers Clinical Trial
Verified date | September 2013 |
Source | University Hospital, Bonn |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
Social touch can convey the most potent and salient of socio-emotional signals. While the hypothalamic peptide oxytocin (OXT) has been identified as a key neurochemical mediator of grooming in some other social species, its modulatory influence on human interpersonal touch is unknown. The investigators expect that OXT augments the hedonic value of touch and that this behavioral effect is paralleled at the neural level by an increased response in brain areas mediating rewarding aspects of social touch.
Status | Completed |
Enrollment | 40 |
Est. completion date | August 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: Healthy male volunteers Exclusion Criteria: Current or past psychiatric disease Current or past physical illness Psychoactive medication Tobacco smokers |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Germany | Department of Psychiatry, University of Bonn | Bonn | North Rhine-Westphalia |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bonn |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Saliva oxytocin concentrations | 15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment | No | |
Primary | Pleasantness ratings of social touch | After each trial, subjects are asked to use a visual analog scale to rate the pleasantness of the administered touch. | 30 minutes after the nasal spray administration | No |
Primary | Blood-oxygen-level dependent signal in response to social touch | By using functional magnetic resonance imaging we want to examine oxytocin's effects on the neural correlates (BOLD signal) of social touch. | 30 minutes after the nasal spray administration | No |
Secondary | Questionnaire measurement of mood (PANAS) and anxiety (STAI). | 15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05523687 -
AME Study of [14C]-PC14586 in Healthy Male Participants
|
Phase 1 | |
Completed |
NCT02250976 -
The Pharmacokinetic Study of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin Ca
|
Phase 1 | |
Completed |
NCT01948011 -
Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules
|
Phase 1 | |
Completed |
NCT04086719 -
An Investigational Study to Determine the Drug Level Profile of BMS-986165 in Healthy Male Volunteers Following Transporter Inhibition.
|
Phase 1 | |
Completed |
NCT03686501 -
D1 Receptor Occupancy (RO) Following a Single Dose of PF-06412562
|
Early Phase 1 | |
Terminated |
NCT01965301 -
First-time-in-man, to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP1.5375
|
Phase 1 | |
Completed |
NCT01005160 -
Drug Interaction Between CKD-501 and Metformin
|
Phase 1 | |
Completed |
NCT04534582 -
Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects
|
Phase 1 | |
Recruiting |
NCT06159101 -
A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX13 With YERVOY in Male Subjects
|
Phase 1 | |
Completed |
NCT01549743 -
The Pharmacokinetic Interaction Between Celecoxib and Rebamipide
|
Phase 1 | |
Completed |
NCT03532854 -
Evaluating a Pharmacokinetic Drug Interaction Between LGEV1801 and LGEV1802
|
Phase 1 | |
Recruiting |
NCT03530228 -
A Phase 1 Study of Tegoprazan on Healthy Male Volunteers
|
Phase 1 | |
Completed |
NCT01356043 -
CKD-828 Drug Interaction Study (S-amlodipine)
|
Phase 1 | |
Completed |
NCT04810533 -
The Absorption, Metabolism and Excretion of [14C]SH-1028 in Chinese Healthy Male Volunteers
|
Phase 1 | |
Completed |
NCT03089112 -
Pharmacokinetic Drug Interactions Between HGP1607 and HGP1501
|
Phase 1 | |
Completed |
NCT01342055 -
Pharmacokinetics and Safety Study of Apetrol ES in Healthy Male Volunteers
|
Phase 1 | |
Terminated |
NCT03863587 -
Compare Pharmacokinetic, Safety, Tolerability and Immunogenicity of HLX12 and Ramucirumab in Healthy Male Adult Subjects
|
Phase 1 | |
Completed |
NCT01606462 -
Oxytocin and Social Cognition
|
Phase 1 | |
Completed |
NCT01356017 -
CKD-828 Drug Interaction Study (Telmisartan)
|
Phase 1 | |
Completed |
NCT01382017 -
Effects of Lacosamide on Human Motor Cortex Excitability: a Transcranial Magnetic Stimulation Study
|
N/A |