A Phase I Randomized Dose/Formulation Comparison Study of SC-52151
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
PRIMARY: To evaluate the safety, tolerability, pharmacokinetics, and ethanol exposure of two
dose regimens and formulations of SC-52151.
SECONDARY: To evaluate the preliminary anti-HIV activity of these treatment regimens and the
relationship between day 14 plasma concentrations of SC-52151 and immunological and
virological markers and toxicity.
Since viral isolates with decreased susceptibility to the protease inhibitor SC-52151 occur
in vitro after multiple passages, and since prolonged post infectious effects occur in vitro,
comparison of two formulations, an elixir and a self-emulsifying drug delivery system
(SEDDS), is needed to determine the appropriate dose formulation for Phase II studies.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)