CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 56 enrolled
Drug / intervention
LY110140 +1 moredrug
Likely dose
LY110140 administered orally as capsules (specific dose not specified in protocol excerpt)AI-extracted
Key inclusion· 3
  • ✓Japanese male, overtly healthy by medical history and physical exam
  • ✓BMI 18.5–29.9 kg/m² at screening
  • ✓Willing to use reliable birth control during study and 3 months after last dose
Key exclusion· 3
  • ✕Poor metabolizer of CYP2D6 (assessed at screening)
  • ✕ECG abnormality, including QTcB >450 msec, that increases study risk per investigator judgment
  • ✕Lifetime history of suicide attempt, suicidal ideation in last month, suicidal behavior in last month, or significant suicide risk per investigator assessment (C-SSRS)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01569126
NCT01569126Phase 1Completed
CompareCT.gov

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY110140 in Healthy Japanese Male Subjects

Eli Lilly and Company·interventional·Posted Apr 2, 2012·Updated Feb 10, 2014

In Brief

A Phase 1 clinical trial evaluating LY110140 and Placebo for Healthy Volunteer. Completed, enrolled 56 participants across 1 site.

Detailed Summary

The purposes of this study are to look at safety, how well the study drug (LY110140) is tolerated, and how much of the study drug gets into the blood stream when given as single dose (SD) and multiple doses (MD) to healthy Japanese male participants. Participants will participate in SD portion for approximately 6 weeks and in MD portion for approximately 10 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteer
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 2, 2012
Enrollment StartApr 1, 2012
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 14.3 years ago

Interventions

LY110140drug

Administered orally as capsules

Placebodrug

Administered orally as capsules in the placebo arm and to maintain the blind in the 20 mg LY110140 (MD) arm