Sinapis Pharma has concluded first Phase I clinical trial of oral and IV administration of methamphetamine HCl for the treatment of stroke and traumatic brain injury.
The single-center, open-label, randomized, two-period, two-treatment, two-sequence, single dose, crossover study assesed the safety and pharmacokinetics of oral and IV administration of methamphetamine HCl in six healthy volunteers.The trial demonstrated the safety of an IV infusion of methamphetamine and produced the IV infusion pharmacokinetics needed to initiate Phase IIa clinical studies in stroke patients.
The company intends to commence Phase IIa trial in stroke patients before the end of this year.Sinapis CEO Donald Picker said they are eager to begin the proof of principle trials in these very important indications where there are currently no effective treatments.
