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A Study of LY2835219 in Healthy Participants

Effect of Food on the Pharmacokinetics of LY2835219 in Healthy Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02059148
Enrollment
24
Registered
2014-02-11
Start date
2014-02-28
Completion date
2014-08-31
Last updated
2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

Participants in this study will receive 3 single oral doses of LY2835219 at least 14 days apart. One dose will be given with a standard meal, one dose with a high-fat meal and one dose without food. The study will evaluate the effects of the standard and high-fat meals on how much drug gets into the bloodstream. Side effects will be documented. This study is approximately 43 days, not including screening. Screening is required within 28 days prior to the start of the study.

Interventions

DRUGLY2835219

Administered orally.

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy sterile males or surgically sterile or postmenopausal females * Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m\^2), inclusive, at screening * Are able to eat a high-fat, high-calorie meal

Exclusion criteria

* Participated in a clinical trial involving investigational product within 30 days * Abnormal blood pressure * Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study * Have donated blood of more than 500 milliliter (mL) within the last month * Show evidence of human immunodeficiency virus, hepatitis B or hepatitis C

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics: Maximum Concentration (Cmax) of LY2835219 Fasted vs. High-Fat ArmsPredose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period
Pharmacokinetics: Area Under the Concentration Curve (0-t Last) [AUC(0-t Last)] of LY2835219 Fasted vs. High-Fat ArmsPredose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period
Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of LY2835219 Fasted vs. High-Fat ArmsPredose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period

Secondary

MeasureTime frameDescription
Pharmacokinetics: Cmax of LY2835219 in Standard Meal ArmPredose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period—
Pharmacokinetics: Area Under the Concentration Curve (AUC 0-t Last) of LSN3106726 (M20)Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each periodArea under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration of LSN3106726 (M20), an active metabolite of LY2835219.
Pharmacokinetics: AUC(0-tlast) of LY2835219 in Standard Meal ArmPredose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period—
Pharmacokinetics: Tmax of LY2835219 in Standard Meal ArmPredose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period—

Countries

United States

Participant flow

Participants by arm

ArmCount
All Study Participants
Single Oral Dose of 200 mg LY2835219 on 3 Occasions: Standard Meal, Fasted State, High-Fat Meal. Dosing occasions were separated by at least 14 days.
24
Total24

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005
Treatment 1Protocol Violation000001

Baseline characteristics

CharacteristicAll Study Participants
Age, Continuous53.9 Years
STANDARD_DEVIATION 9.5
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
13 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
9 Participants
Region of Enrollment
United States
24 Participants
Sex: Female, Male
Female
21 Participants
Sex: Female, Male
Male
3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
4 / 236 / 234 / 24
serious
Total, serious adverse events
0 / 230 / 230 / 24

Outcome results

Primary

Pharmacokinetics: Area Under the Concentration Curve (0-t Last) [AUC(0-t Last)] of LY2835219 Fasted vs. High-Fat Arms

Time frame: Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period

Population: All randomized participants receiving at least one dose of the investigational product.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
LY2835219 FastedPharmacokinetics: Area Under the Concentration Curve (0-t Last) [AUC(0-t Last)] of LY2835219 Fasted vs. High-Fat Arms4160 nanogram*hour/mL (ng*h/mL)Geometric Coefficient of Variation 65
LY2835219 High-FatPharmacokinetics: Area Under the Concentration Curve (0-t Last) [AUC(0-t Last)] of LY2835219 Fasted vs. High-Fat Arms4790 nanogram*hour/mL (ng*h/mL)Geometric Coefficient of Variation 57
90% CI: [1.05, 1.23]
Primary

Pharmacokinetics: Maximum Concentration (Cmax) of LY2835219 Fasted vs. High-Fat Arms

Time frame: Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period

Population: All randomized participants receiving at least one dose of the investigational product.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
LY2835219 FastedPharmacokinetics: Maximum Concentration (Cmax) of LY2835219 Fasted vs. High-Fat Arms111 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 61
LY2835219 High-FatPharmacokinetics: Maximum Concentration (Cmax) of LY2835219 Fasted vs. High-Fat Arms137 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 52
90% CI: [1.11, 1.38]
Primary

Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of LY2835219 Fasted vs. High-Fat Arms

Time frame: Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period

Population: All randomized participants receiving at least one dose of the investigational product.

ArmMeasureValue (MEDIAN)
LY2835219 FastedPharmacokinetics: Time of Maximum Observed Concentration (Tmax) of LY2835219 Fasted vs. High-Fat Arms8.00 hour (h)
LY2835219 High-FatPharmacokinetics: Time of Maximum Observed Concentration (Tmax) of LY2835219 Fasted vs. High-Fat Arms10.00 hour (h)
p-value: 0.000690% CI: [1, 2]Wilcoxon (Mann-Whitney)
Secondary

Pharmacokinetics: Area Under the Concentration Curve (AUC 0-t Last) of LSN3106726 (M20)

Area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration of LSN3106726 (M20), an active metabolite of LY2835219.

Time frame: Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period

Population: All randomized participants receiving at least one dose of the investigational product.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
LY2835219 FastedPharmacokinetics: Area Under the Concentration Curve (AUC 0-t Last) of LSN3106726 (M20)3590 ng*h/mLGeometric Coefficient of Variation 35
LY2835219 High-FatPharmacokinetics: Area Under the Concentration Curve (AUC 0-t Last) of LSN3106726 (M20)3320 ng*h/mLGeometric Coefficient of Variation 40
LY2835219 High-FatPharmacokinetics: Area Under the Concentration Curve (AUC 0-t Last) of LSN3106726 (M20)3510 ng*h/mLGeometric Coefficient of Variation 35
Secondary

Pharmacokinetics: AUC(0-tlast) of LY2835219 in Standard Meal Arm

Time frame: Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period

Population: All randomized participants receiving at least one dose of the investigational product.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
LY2835219 FastedPharmacokinetics: AUC(0-tlast) of LY2835219 in Standard Meal Arm4610 ng*h/mLGeometric Coefficient of Variation 65
Secondary

Pharmacokinetics: Cmax of LY2835219 in Standard Meal Arm

Time frame: Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period

Population: All randomized participants receiving at least one dose of the investigational product.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
LY2835219 FastedPharmacokinetics: Cmax of LY2835219 in Standard Meal Arm141 ng/mLGeometric Coefficient of Variation 55
Secondary

Pharmacokinetics: Tmax of LY2835219 in Standard Meal Arm

Time frame: Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period

Population: All randomized participants receiving at least one dose of the investigational product.

ArmMeasureValue (MEDIAN)
LY2835219 FastedPharmacokinetics: Tmax of LY2835219 in Standard Meal Arm8.00 hour (h)

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026