CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 33 enrolled
Drug / intervention
Baricitinib +1 moredrug
Likely dose
Baricitinib orally (specific dose not stated)AI-extracted
Key inclusion· 3
  • ✓Healthy Chinese males (using birth control) or postmenopausal females
  • ✓Body mass index 19.0-24.0 kg/m²
  • ✓Clinical laboratory tests within normal reference range or with acceptable deviations not clinically significant
Key exclusion· 9
  • ✕History of adverse drug reactions or allergy to more than 3 systemically administered medications
  • ✕Abnormality in 12-lead ECG
  • ✕History of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders that could alter drug absorption/metabolism/elimination or pose risk
  • ✕History of stomach or intestinal surgery

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

Search/NCT02758613
NCT02758613Phase 1Completed
CompareCT.gov

A Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3009104 in Healthy Chinese Subjects

Eli Lilly and Company·interventional·Posted May 2, 2016·Updated Dec 7, 2017

In Brief

A Phase 1 clinical trial evaluating Baricitinib and Placebo for Healthy. Completed, enrolled 33 participants across 1 site.

Detailed Summary

The main purpose of this study is to investigate the safety and tolerability of the study drug known as baricitinib in healthy Chinese participants. The study will measure how the body absorbs, breaks down and gets rid of baricitinib. The study will last about 20 days, not including screening. This study is for research purposes only, and is not intended to treat any medical condition.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2, 2016
Enrollment StartMay 1, 2016
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.2 years ago

Interventions

Baricitinibdrug

Administered orally.

Placebodrug

Administered orally.