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A Study of LY2216684 and Theophylline in Healthy Subjects

NCT01263106 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-07-08

Study results available
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Summary

The primary objective of this study is to confirm that LY2216684 is not an inhibitor of cytochrome P450 1A2 (CYP1A2) in healthy participants using theophylline as a probe substrate for the enzyme. Because LY2216684 has been observed to increase heart rate in some healthy participants, this study will also assess heart rate when coadministered with theophylline.

Conditions

Interventions

DRUG

LY2216684

18-mg LY2216684 oral dose

DRUG

Theophylline

200-mg theophylline oral dose

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
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01263106 on ClinicalTrials.gov