An open-label study to evaluate the transition of patients with chronic plaque psoriasis from cyclosporine to alefacept.

Eleven patients with well-controlled psoriasis on cyclosporine (Physician's Global Assessment [PGA] of "mild" or better) participated in an open-label study that evaluated a strategy for transition to alefacept. Using this transition strategy, 7 of 11 patients (64%) maintained PGA scores. Quality of life improved or was maintained in all patients.

FTY720 and cyclosporine: evaluation for a pharmacokinetic interaction.

Background: FTY720 is a sphingosine-1-phosphate receptor agonist intended for use in immunoprophylaxis regimens to prevent acute rejection after organ transplantation.

Objective: To evaluate the potential for a pharmacokinetic drug interaction between the immunomodulator FTY720 and cyclosporine to support the use of this drug combination in organ transplantation.

Methods: In this open-label, randomized crossover study, 12 subjects with psoriasis received a single dose of FTY720 1 mg alone and on day 5 of an 8-day course of cyclosporine 200 mg twice daily.

Tolerability, pharmacokinetics, and serum bactericidal activity of intravenous dalbavancin in healthy volunteers.

Fifty-two healthy adult male and female volunteers were enrolled in this double-blind study to determine the maximum tolerated dose, characterize the pharmacokinetics, and obtain serum bactericidal activity (SBA) data for intravenous dalbavancin. Subjects were assigned to single- or multiple-dose groups and randomized to receive dalbavancin or placebo intravenously over 30 min. Doses started at 140 mg in the single-dose group and with a 300-mg loading dose (LD), followed by six daily 30-mg maintenance doses (MDs), in the multiple-dose cohort and escalated to a 1120-mg single dose and a 1000-mg LD and 100-mg MD regimen.

Audiologic monitoring for potential ototoxicity in a phase I clinical trial of a new glycopeptide antibiotic.

This study describes audiologic methodology and results for evaluating potential ototoxicity in a phase I clinical trial of a new glycopeptide. This study was conducted under good clinical practices, which are regulated by the US Food and Drug Administration (FDA) (21 Code of Federal Regulations), and input from the FDA was sought prior to study implementation. Healthy, normal volunteers underwent extensive medical and audiologic assessments as part of this phase I dose- escalation study of dalbavancin, a new glycopeptide, to assess potential side effects.