Clinical Trials Logo

Clinical Trial Summary

A recent study by Plenge et al. revealed that rhEpo treatment enhances skeletal muscle mitochondrial respiratory capacity in humans indicating a muscle ergogenic effect of rhEpo on aerobic metabolism. The main purpose of the present study is to determine if a shorter treatment period with micro-dose as well as low-dose rhEpo has similar effects on muscle mitochondrial function.

Higher doses of rhEpo is known to increase cognitive performance, but it is not clear if lower doses of rhEpo have similar effects. A second purpose of the present study is to determine if micro-dose as well as low-dose rhEpo increases cognitive performance.


Clinical Trial Description

Twenty-five healthy young male volunteers are randomized to either a low-dose rhEpo (60 IU/kg/week), micro-dose rhEpo (20 IU/kg/week), or placebo control (saline) group. All subjects receive two subcutaneous injections per week for four weeks. Muscle biopsies are taken at the beginning and end of the study period. Mitochondrial function is measured in permeabilized fibres using high-resolution respirometry with the substrates malate (2mM), octanoyl carnitine (1.5mM), glutamate (10mM), succinate (10mM), under saturating [ADP] (5mM), and with the membrane uncoupler FCCP (1μM).

On the first day before administration of rhEpo and after the four weeks' treatment the subjects are undergoing two cognitive performance-tests, Raven Standard Progressive Matrices (Raven), and Number Finder (NUFI). Weekly semi-structured interviews are conducted by a blinded interviewer focusing on experienced change in cognitive performance. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03093506
Study type Interventional
Source Bispebjerg Hospital
Contact
Status Completed
Phase Early Phase 1
Start date September 2011
Completion date December 2011

See also
  Status Clinical Trial Phase
Completed NCT00526968 - The Effects of a Novel NMDA NR2B-Subtype Selective Antagonist, EVT 101, on Brain Function Phase 1
Completed NCT03277456 - A Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine MVA-NP+M1 Early Phase 1
Completed NCT02922933 - A Study to Examine the Effect of Omeprazole, Famotidine, and an Acidic Beverage on the Pharmacokinetics of Entinostat in Healthy Adult Subjects Phase 1
Completed NCT01452425 - In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome Phase 1
Completed NCT01468714 - A Study To Estimate The Effect Of Ketoconazole On The Pharmacokinetics Of Pf-04937319 In Healthy Subjects Phase 1
Completed NCT01464385 - Nutrition Beverage Tolerance Study Phase 2
Completed NCT02922946 - Study to Determine the Effect of the Timing of a Meal on the Pharmacokinetics of Entinostat Phase 1
Completed NCT00254449 - Effect of NGX-4010 on ENFD and Sensory Function Phase 1
Completed NCT01618877 - A Randomized, Double-blind, Pharmacokinetics Study to Assess Safety, Tolerability of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of Bid Dosing in Chinese Healthy Volunteers Phase 1
Completed NCT01618903 - An Open-label, Bioequivalence Study to Evaluate LEV Administered as a 45-min Intravenous Infusion and Same Dosage LEV Oral Tablet in Chinese Phase 1
Completed NCT00752466 - A Drug Interaction Study of the Pharmacokinetics of Topiramate and FLUNARIZINE When Given Together or Separately Phase 1
Completed NCT00166933 - Minimal Erythema Dose of UV-B in Normal Population of Taiwan N/A
Completed NCT05519514 - Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult Subjects Phase 1
Completed NCT01776437 - Study of BMN 673, a PARP Inhibitor, in Healthy Adult Male Volunteers Phase 1
Completed NCT01437033 - Breath Test for Chemicals (Volatile Organic Compounds)
Completed NCT01445860 - Drug-Drug Interaction Study Of Effect Of PF-03882845 On Simvastatin Pharmacokinetics Phase 1
Completed NCT00744809 - TMC278-TiDP6-C152: A Study to Assess the Effects of TMC278 and Efavirenz (EFV) on the QT/QTc Interval (Heart Conduction and Heart Rhythm) in Healthy Volunteers. Phase 1
Unknown status NCT00743977 - Bioequivalence of Phenazopyridine HCl in Healthy Volunteers N/A