Clinical Trial: A Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase IIa Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of Vamorolone in Boys With Duchenne
Current Secondary Outcome:
- Peak plasma concentration (Cmax) of vamorolone [ Time Frame: Day 1 ]
- Peak plasma concentration (Cmax) of vamorolone [ Time Frame: Week 2 ]
- Serum pharmacodynamics biomarkers measured by levels of cortisol [ Time Frame: 4 weeks ]
- Serum pharmacodynamics biomarkers measured by levels of ACTH [ Time Frame: 4 weeks ]
- Serum pharmacodynamics biomarkers measured by levels of PINP [ Time Frame: 4 weeks ]
- Serum pharmacodynamics biomarkers measured by levels of osteocalcin [ Time Frame: 4 weeks ]
- Serum pharmacodynamics biomarkers measured by levels of CTX [ Time Frame: 4 weeks ]
- Serum pharmacodynamics biomarkers measured by levels of 17-hydroxyprogesterone [ Time Frame: 4 weeks ]
- Serum pharmacodynamics biomarkers measured by levels of testosterone [ Time Frame: 4 weeks ]
- Serum pharmacodynamics biomarkers measured by levels of corticosterone [ Time Frame: 4 weeks ]
- Serum pharmacodynamics biomarkers measured by levels of 11-deoxycortisol [ Time Frame: 4 weeks ]
- Serum pharmacodynamics biomarkers measured by levels of glucose [ Time Frame: 2 weeks ]
- Serum pharmacodynamics biomarkers measured by levels of insulin [ Time Frame: 2 weeks ]
- Serum metabolites of vamorolone [ Time Frame: Week 2 ]Metabolites in Safety Testing (MIST)
Original Secondary Outcome:
- Peak plasma concentration (Cmax) of vamorolone [ Time Frame: Day 1 ]
- Peak plasma concentration (Cmax) of vamorolone [ Time Frame: Week 2 ]
- Serum pharmacodynamics biomarkers measured by levels of cortisol, ACTH, PINP, osteocalcin, CTX, 17-hydroxyprogesterone, testosterone, corticosterone, 11-deoxycortisol, glucose and insulin [ Time Frame: Week 2 ]
- Serum metabolites of vamorolone [ Time Frame: Week 2 ]Metabolites in Safety Testing (MIST)
Information By: ReveraGen BioPharma, Inc.
Dates:
Date Received: April 28, 2016
Date Started: June 2016
Date Completion: August 2017
Last Updated: April 5, 2017
Last Verified: April 2017