The purpose of this study is to assess the effect LY2603618 on a protein \[enzyme cytochrome P (CYP) 2D6\] which is involved in the metabolic pathway of Desipramine in participants with cancer. This is a drug interaction study so the treatment of the disease will not be the main purpose of the study. The study involves two single doses of 50 milligrams (mg), 1 tablet by mouth, on Day 1 of Period 1 and 2. In Period 1 Desipramine will be administered alone. In Period 2 Desipramine will be administered in combination with LY2603618. LY2603618 will be administered as a 275mg intravenous (IV) infusion over 1 hour (hr). Desipramine will be administered at the end of the LY2603618 infusion. Information about any side effects that may occur will also be collected.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Administered intravenously as a 1-hour infusion.
Administered orally
Administered intravenously as a 10-minute infusion.
Administered intravenously as a 30-minute infusion.
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.
Memphis, Tennessee, United States
Plasma Pharmacokinetics of LY2603618: the Maximum Concentration of LY2603618 in the Plasma (Cmax)
Time frame: Period 2 only: Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours post dose
Plasma Pharmacokinetics of Desipramine: the Maximum Concentration of Desipramine in the Plasma (Cmax)
Time frame: Periods 1 and 2: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post dose
Plasma Pharmacokinetics of LY2603618: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)]
Time frame: Period 2 only: Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours post dose
Plasma Pharmacokinetics of Desipramine: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)]
Time frame: Periods 1 and 2: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post dose
Plasma Pharmacokinetics of LY2603618: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Observed Plasma Concentration of LY2603618 [AUC(0-tlast)]
Time frame: Period 2 only: Predose 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours post dose
Plasma Pharmacokinetics of Desipramine: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Observed Plasma Concentration of Desipramine [AUC(0-tlast)]
Time frame: Periods 1 and 2: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post dose
Number of Participants With a Tumor Response
Tumor response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1). CR is the disappearance of all target and non-target lesions and PR is a ≥30% decrease in sum of longest diameter of target lesions. Number of participants with a tumor response is the total number of participants with CR or PR.
Time frame: Baseline to study completion up to 11 cycles of 21-day cycles
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