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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
18-mg LY2216684 oral dose
200-mg theophylline oral dose
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dallas, Texas, United States
Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of Theophylline
The Least Squares (LS) geometric mean was based on AUC0-∞. The AUC for theophylline was calculated on Day 1 of a given period when theophylline was administered alone and on Day 3 of another period when theophylline was coadministered with LY2216684.
Time frame: Predose 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-administration of theophylline on Days 1 and 3
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Theophylline
The Least Squares (LS) geometric mean was based on Cmax for theophylline on Day 1 of a given period when theophylline was administered alone and on Day 3 of another period when theophylline was coadministered with LY2216684.
Time frame: Predose 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-administration of theophylline on Days 1 and 3
Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of Theophylline
This outcome was measured based on Tmax for theophylline on Day 1 of a given period when theophylline was administered alone and on Day 3 of another period when theophylline was coadministered with LY2216684.
Time frame: Predose 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-administration of theophylline on Days 1 and 3
Mean Change From Baseline in Heart Rate: 200 mg Theophylline
Time frame: Baseline, Day 1
Mean Change From Baseline in Heart Rate: 18 mg LY221684 + 200 mg Theophylline
Time frame: Baseline, Day 1, Day 3
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