Clinical Trial: Safety, Tolerability, and Pharmacokinetic Study of Methylene Blue Following a 1 mg/kg Intravenous Dose in Healthy Adults

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A One-Period, Single-Dose, Safety, Tolerability, and Pharmacokinetic Study of Methylene Blue Injection USP Following a 1 mg/kg Intravenous Dose in Healthy Adult Volunteers

Brief Summary: A Phase 1 trial to assess the single-dose safety, tolerability, and pharmacokinetic (PK) of Methylene Blue Injection, USP 1 mg/kg in healthy adult voluneetrs.

Detailed Summary: This is an open-label, single-center, one-arm, safety, tolerability, and PK study in healthy male and female volunteers of Methylene Blue Injection, USP. Following an overnight fast, twelve healthy adult male and female volunteers will receive a single dose of study drug at a dose of 1 mg/kg solution per kg given intravenously over a period of 5 minutes followed by serial venous blood sampling at 0.042, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 16, 36, 48, and 72 hours postdose.
Sponsor: Luitpold Pharmaceuticals

Current Primary Outcome:

  • Assess the AUC0-t (ng*hr/mL) of Methylene Blue [ Time Frame: 72 hours postdose ]
  • Assess the AUC0- infinity (ng*hr/mL) of Methylene Blue [ Time Frame: 72 hours postdose ]
  • Assess the AUC%extrap (%) of Methylene Blue [ Time Frame: 72 hours postdose ]
  • Assess the AUCR (%) of Methylene Blue [ Time Frame: 72 hours postdose ]
  • Assess the CL (L/hr) of Methylene Blue [ Time Frame: 72 hours postdose ]
  • Assess the Cmax (ng/mL) of Methylene Blue [ Time Frame: 72 hours postdose ]
  • Assess the tmax (hr) of Methylene Blue [ Time Frame: 72 hours postdose ]
  • Assess the t½ (hr) of Methylene Blue [ Time Frame: 72 hours postdose ]
  • Asses the λz (1/hr) of Methylene Blue [ Time Frame: 72 hours postdose ]
  • Assess the Vz (L) of Methylene Blue [ Time Frame: 72 hours postdose ]
  • Assess the MRT (hr) of Methylene Blue [ Time Frame: 72 hours postdose ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Luitpold Pharmaceuticals

Dates:
Date Received: April 28, 2015
Date Started: October 2012
Date Completion:
Last Updated: June 18, 2015
Last Verified: June 2015