Single Dose Study in Healthy Participants to Investigate the Safety and Absorption of LY2584702

NCT01372085 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2019-01-22

Study results available
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Summary

This is a single-centre, placebo-controlled, two-part study in healthy participants.

Part A will be a single dose, single period, placebo-controlled pilot study to explore the safety, tolerability, absorption and pharmacodynamic \[effect of drug on a biological marker-phospho-S6 (pS6) levels in skin biopsies\] of a single dose of 25 milligrams (mg) LY2584702 Reference formulation (RF). Part B is a single dose, placebo-controlled, 4-period crossover study to primarily evaluate the absorption of the Test Formulation (TF) in comparison with the (RF) of LY2584702.

Conditions

  • Healthy Participants

Interventions

DRUG

LY2584702 Reference Formulation

Administered orally

DRUG

LY2584702 Test Formulation

Administered orally

DRUG

Placebo

Administered orally

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01372085 on ClinicalTrials.gov