A Study of LY3127760 in Healthy Participants

A Single- and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of LY3127760 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01968070

Enrollment

Registered

2013-10-23

Start date

2013-10-31

Completion date

2014-04-30

Last updated

2019-06-07

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

Conditions

Healthy Volunteers

Brief summary

The main purposes of this study are to evaluate the safety and how well the body handles single and multiple doses of increasing strength of study drug, LY3127760. This study includes three parts. Part 3 may be initiated at sponsor's discretion, based on data from Part 2. Participants will only enroll in 1 of the 3 study parts. This study will last approximately 7 to 13 weeks, depending on part. Screening must be completed within 28 days prior to enrollment.

Interventions

DRUGLY3127760

Administered orally

DRUGCelecoxib

Administered orally

DRUGPlacebo

Administered orally

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Overtly healthy males or females as determined by medical history and physical examination * Male participants agree to use a reliable method of birth control during the study and 3 months following the last dose of the investigational product * Female participants not of child-bearing potential * Have a body mass index of 18.5 to 32 kilograms per square meter (kg/m\^2) inclusive * Are normotensive (defined as supine systolic blood pressure \[BP\] less than 140 millimeters of mercury \[mm Hg\] and diastolic BP less than 90 mm Hg) without use of any antihypertensives

Exclusion criteria

* Have known allergies to LY3127760, related compounds or any components of the formulation, celecoxib or sulfonamides, or history of significant atopy. Participants with known aspirin allergy or allergic reactions to nonsteroidal anti-inflammatory drugs (NSAIDs) should also be excluded * Have any current or prior history of a significant gastrointestinal illness such as peptic ulcer disease, gastrointestinal (GI) bleeding, chronic gastritis, inflammatory bowel disease or chronic diarrhea * Have evidence of other chronic liver disease, including but not limited to chronic alcoholic disease, nonalcoholic steatohepatitis, recent history (within 3 months of screening) of acute viral hepatitis or chronic autoimmune hepatitis * Have used any NSAIDs, celecoxib, aspirin or acetaminophen (at doses greater than 1 gram per day), anticoagulants or antiplatelet agents within 14 days of admission Part 2 and Part 3 only * Have 1 plus pretrial pitting edema or 2 plus ankle or pedal edema

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline to Study Completion (Up To Day 42)	Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.

Secondary

Measure	Time frame	Description
PK: Maximum Observed Concentration (Cmax) of Single Dose LY3127760	Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours	—
PK: Time of Maximum Observed Concentration (Tmax) of Single Dose LY3127760	Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours	—
Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Zero to Infinity (AUC 0-∞) of Single Dose LY3127760	Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours	—
PK: Cmax of Multiple Doses LY3127760	Post last dose on Day 28: 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 72, and 168 Hours	—
PK: Tmax of Multiple Doses LY3127760	Post-last dose on Day 28: 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 72, and 168 Hours	—
PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC-tau (τ)] of Multiple Doses LY3127760	Day 28: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, and 24 Hours	AUC-tau (τ) where τ is 24-hours for the 20 mg, 60 mg, and 200 mg cohorts, and 12-hours for the 300 mg cohort.

Countries

United States

Participant flow

Pre-assignment details

Part 1 was a single-ascending dose, 2-cohort, 3-period, alternating-group dose-escalation study (cohorts 1-2) and Part 2 of the study was a multiple-ascending dose, 4-cohort, parallel-group, dose-escalation study (cohorts 3-6). Replacement participants received interventions intended for those participants whom discontinued early.

Participants by arm

Arm	Count
Cohort 1 Sequence 1 Participants received either placebo or 20 milligram (mg) or 200mg LY3127760 capsules orally as per the below dosing sequence. Period 1: 20mg LY3127760; Period 2: 200mg LY3127760; Period 3: Placebo;	4
Cohort 1 Sequence 2 Participants received either placebo or 20 milligram (mg) or 900mg LY3127760 capsules orally as per the below dosing sequence. Period 1: 20mg LY3127760; Period 2: Placebo; Period 3: 900mg LY3127760;	5
Cohort 1 Sequence 3 Participants received either placebo or 200 milligram(mg) or 900mg LY3127760 capsules orally as per the below dosing sequence. Period 1: Placebo; Period 2: 200 mg LY3127760; Period 3: 900 mg LY3127760;	4
Cohort 2 Sequence 1 Participants received either 60mg or 600mg LY3127760 capsules orally as per the below dosing sequence. Period 1: 60 mg LY3127760; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state;	6
Cohort 2 Sequence 2 Participants received either placebo or 60 mg LY3127760 capsules orally as per the below dosing sequence. Period 1: 60 mg LY3127760; Period 2: Placebo; Period 3: Placebo;	4
Cohort 2 Sequence 3 Participants received either Placebo or 600 mg LY3127760 capsules orally as per the below dosing sequence. Period 1: Placebo; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state;	4
Cohort 3 LY3127760 60mg Participants received 60mg LY3127760 capsules orally once daily.	10
Cohort 3 Placebo Participants received placebo capsules orally once daily.	2
Cohort 3 Celecoxib 400mg Participants received 400mg Celecoxib capsules orally once daily.	2
Cohort 4 LY3127760 200mg Participants received 200mg LY3127760 capsules orally once daily.	9
Cohort 4 Placebo Participants received placebo capsules orally once daily.	2
Cohort 4 Celcoxib 400mg Participants received 400mg Celecoxib capsules orally once daily.	2
Cohort 5 LY3127760 20mg Participants received 20mg LY3127760 capsules orally once daily.	9
Cohort 5 Placebo Participants received placebo capsules orally once daily.	2
Cohort 5 Celecoxib 400mg Participants received 400mg Celecoxib capsules orally once daily.	2
Cohort 6 LY3127760 300mg Participants received 300mg LY3127760 capsules orally twice daily.	9
Cohort 6 Placebo Participants received placebo capsules orally once daily.	2
Cohort 6 Celecoxib 400mg Participants received 400mg Celecoxib capsules orally once daily.	2
Total	80

Withdrawals & dropouts

Period	Reason	FG001	FG003	FG004	FG006	FG011	FG015
Period 1	Adverse Event	0	0	0	1	0	0
Period 1	Lost to Follow-up	0	1	0	0	0	0
Period 1	Physician Decision	0	0	0	0	1	0
Period 1	Protocol Violation	0	1	1	0	0	0
Period 1	Withdrawal by Subject	1	0	0	1	0	1
Period 2	Withdrawal by Subject	0	0	1	0	0	0

Baseline characteristics

Characteristic	Total	Cohort 1 Sequence 2	Cohort 1 Sequence 3	Cohort 2 Sequence 1	Cohort 2 Sequence 2	Cohort 2 Sequence 3	Cohort 3 LY3127760 60mg	Cohort 3 Placebo	Cohort 3 Celecoxib 400mg	Cohort 4 LY3127760 200mg	Cohort 1 Sequence 1	Cohort 4 Placebo	Cohort 4 Celcoxib 400mg	Cohort 5 LY3127760 20mg	Cohort 5 Placebo	Cohort 5 Celecoxib 400mg	Cohort 6 LY3127760 300mg	Cohort 6 Placebo	Cohort 6 Celecoxib 400mg
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	80 Participants	5 Participants	4 Participants	6 Participants	4 Participants	4 Participants	10 Participants	2 Participants	2 Participants	9 Participants	4 Participants	2 Participants	2 Participants	9 Participants	2 Participants	2 Participants	9 Participants	2 Participants	2 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	80 Participants	5 Participants	4 Participants	6 Participants	4 Participants	4 Participants	10 Participants	2 Participants	2 Participants	9 Participants	4 Participants	2 Participants	2 Participants	9 Participants	2 Participants	2 Participants	9 Participants	2 Participants	2 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	28 Participants	0 Participants	2 Participants	0 Participants	2 Participants	1 Participants	3 Participants	1 Participants	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	4 Participants	2 Participants	1 Participants	5 Participants	0 Participants	1 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	47 Participants	5 Participants	1 Participants	6 Participants	1 Participants	2 Participants	7 Participants	1 Participants	1 Participants	6 Participants	3 Participants	1 Participants	1 Participants	4 Participants	0 Participants	1 Participants	4 Participants	2 Participants	1 Participants
Region of Enrollment United States	80 participants	5 participants	4 participants	6 participants	4 participants	4 participants	10 participants	2 participants	2 participants	9 participants	4 participants	2 participants	2 participants	9 participants	2 participants	2 participants	9 participants	2 participants	2 participants
Sex: Female, Male Female	22 Participants	2 Participants	2 Participants	2 Participants	2 Participants	0 Participants	4 Participants	1 Participants	0 Participants	1 Participants	3 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Sex: Female, Male Male	58 Participants	3 Participants	2 Participants	4 Participants	2 Participants	4 Participants	6 Participants	1 Participants	2 Participants	8 Participants	1 Participants	2 Participants	0 Participants	9 Participants	1 Participants	2 Participants	8 Participants	1 Participants	2 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk	EG011 affected / at risk	EG012 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	4 / 19	2 / 8	1 / 8	1 / 8	3 / 8	1 / 8	2 / 8	2 / 8	4 / 9	5 / 10	4 / 9	6 / 9	3 / 8
serious Total, serious adverse events	0 / 19	0 / 8	0 / 8	0 / 8	0 / 8	0 / 8	0 / 8	0 / 8	0 / 9	0 / 10	0 / 9	0 / 9	0 / 8

Outcome results

Primary

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.

Time frame: Baseline to Study Completion (Up To Day 42)

Population: All randomized participants who received at least one dose of study drug.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Part 1: Placebo	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	0 Participants
Part 1: 20 mg LY3127760	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	0 Participants
Part 1: 60 mg LY3127760	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	0 Participants
Part 1: 200 mg LY3127760	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	0 Participants
Part 1: 600 mg LY3127760	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	0 Participants
Part 1: 600 mg LY3127760 (Fasted)	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	0 Participants
Part 1: 900 mg LY3127760	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	0 Participants
Part 2: Placebo	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	0 Participants
Part 2: 20 mg LY3127760	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	0 Participants
Part 2: 60 mg LY3127760	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	0 Participants
Part 2: 200 mg LY3127760	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	0 Participants
Part 2: 300 mg LY3127760	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	0 Participants
Part 2: 400 mg Celecoxib	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	0 Participants

Secondary

Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Zero to Infinity (AUC 0-∞) of Single Dose LY3127760

Time frame: Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours

Population: All randomized participants who received at least one dose of study drug for the single dose in Part 1 and had evaluable AUC data.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part 1: Placebo	Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Zero to Infinity (AUC 0-∞) of Single Dose LY3127760	NA nanograms•hour/milliliter (ng•hr/mL)	—
Part 1: 20 mg LY3127760	Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Zero to Infinity (AUC 0-∞) of Single Dose LY3127760	3010 nanograms•hour/milliliter (ng•hr/mL)	Geometric Coefficient of Variation 42
Part 1: 60 mg LY3127760	Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Zero to Infinity (AUC 0-∞) of Single Dose LY3127760	17200 nanograms•hour/milliliter (ng•hr/mL)	Geometric Coefficient of Variation 9
Part 1: 200 mg LY3127760	Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Zero to Infinity (AUC 0-∞) of Single Dose LY3127760	40000 nanograms•hour/milliliter (ng•hr/mL)	Geometric Coefficient of Variation 17
Part 1: 600 mg LY3127760	Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Zero to Infinity (AUC 0-∞) of Single Dose LY3127760	47400 nanograms•hour/milliliter (ng•hr/mL)	Geometric Coefficient of Variation 20
Part 1: 600 mg LY3127760 (Fasted)	Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Zero to Infinity (AUC 0-∞) of Single Dose LY3127760	71900 nanograms•hour/milliliter (ng•hr/mL)	Geometric Coefficient of Variation 20

Secondary

PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC-tau (τ)] of Multiple Doses LY3127760

AUC-tau (τ) where τ is 24-hours for the 20 mg, 60 mg, and 200 mg cohorts, and 12-hours for the 300 mg cohort.

Time frame: Day 28: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, and 24 Hours

Population: All randomized participants who received at least one dose of study drug for multiple dosing in Part 2 and had evaluable AUC data.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part 1: Placebo	PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC-tau (τ)] of Multiple Doses LY3127760	1020 ng•hr/ml	Geometric Coefficient of Variation 20
Part 1: 20 mg LY3127760	PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC-tau (τ)] of Multiple Doses LY3127760	4350 ng•hr/ml	Geometric Coefficient of Variation 50
Part 1: 60 mg LY3127760	PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC-tau (τ)] of Multiple Doses LY3127760	11300 ng•hr/ml	Geometric Coefficient of Variation 23
Part 1: 200 mg LY3127760	PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC-tau (τ)] of Multiple Doses LY3127760	19700 ng•hr/ml	Geometric Coefficient of Variation 15

Secondary

PK: Cmax of Multiple Doses LY3127760

Time frame: Post last dose on Day 28: 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 72, and 168 Hours

Population: All randomized participants who received at least one dose of study drug for multiple dosing in Part 2 and had evaluable Cmax data.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part 1: Placebo	PK: Cmax of Multiple Doses LY3127760	301 ng/mL	Geometric Coefficient of Variation 19
Part 1: 20 mg LY3127760	PK: Cmax of Multiple Doses LY3127760	1210 ng/mL	Geometric Coefficient of Variation 53
Part 1: 60 mg LY3127760	PK: Cmax of Multiple Doses LY3127760	3650 ng/mL	Geometric Coefficient of Variation 27
Part 1: 200 mg LY3127760	PK: Cmax of Multiple Doses LY3127760	6170 ng/mL	Geometric Coefficient of Variation 22

Secondary

PK: Maximum Observed Concentration (Cmax) of Single Dose LY3127760

Time frame: Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours

Population: All randomized participants who received at least one dose of study drug for the single dose in Part 1 and had evaluable Cmax data.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part 1: Placebo	PK: Maximum Observed Concentration (Cmax) of Single Dose LY3127760	264 nanograms/milliliter (ng/mL)	Geometric Coefficient of Variation 41
Part 1: 20 mg LY3127760	PK: Maximum Observed Concentration (Cmax) of Single Dose LY3127760	890 nanograms/milliliter (ng/mL)	Geometric Coefficient of Variation 19
Part 1: 60 mg LY3127760	PK: Maximum Observed Concentration (Cmax) of Single Dose LY3127760	3880 nanograms/milliliter (ng/mL)	Geometric Coefficient of Variation 33
Part 1: 200 mg LY3127760	PK: Maximum Observed Concentration (Cmax) of Single Dose LY3127760	10300 nanograms/milliliter (ng/mL)	Geometric Coefficient of Variation 37
Part 1: 600 mg LY3127760	PK: Maximum Observed Concentration (Cmax) of Single Dose LY3127760	18900 nanograms/milliliter (ng/mL)	Geometric Coefficient of Variation 40
Part 1: 600 mg LY3127760 (Fasted)	PK: Maximum Observed Concentration (Cmax) of Single Dose LY3127760	21600 nanograms/milliliter (ng/mL)	Geometric Coefficient of Variation 27

Secondary

PK: Time of Maximum Observed Concentration (Tmax) of Single Dose LY3127760

Time frame: Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours

Population: All randomized participants who received at least one dose of study drug for the single dose in Part 1 and had evaluable Tmax data.

Arm	Measure	Value (MEDIAN)
Part 1: Placebo	PK: Time of Maximum Observed Concentration (Tmax) of Single Dose LY3127760	2.00 Hour
Part 1: 20 mg LY3127760	PK: Time of Maximum Observed Concentration (Tmax) of Single Dose LY3127760	2.00 Hour
Part 1: 60 mg LY3127760	PK: Time of Maximum Observed Concentration (Tmax) of Single Dose LY3127760	2.00 Hour
Part 1: 200 mg LY3127760	PK: Time of Maximum Observed Concentration (Tmax) of Single Dose LY3127760	2.00 Hour
Part 1: 600 mg LY3127760	PK: Time of Maximum Observed Concentration (Tmax) of Single Dose LY3127760	1.00 Hour
Part 1: 600 mg LY3127760 (Fasted)	PK: Time of Maximum Observed Concentration (Tmax) of Single Dose LY3127760	1.50 Hour

Secondary

PK: Tmax of Multiple Doses LY3127760

Time frame: Post-last dose on Day 28: 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 72, and 168 Hours

Population: All randomized participants who received at least one dose of study drug for multiple dosing in Part 2 and had evaluable Tmax data.

Arm	Measure	Value (MEDIAN)
Part 1: Placebo	PK: Tmax of Multiple Doses LY3127760	2.00 hour
Part 1: 20 mg LY3127760	PK: Tmax of Multiple Doses LY3127760	1.65 hour
Part 1: 60 mg LY3127760	PK: Tmax of Multiple Doses LY3127760	2.00 hour
Part 1: 200 mg LY3127760	PK: Tmax of Multiple Doses LY3127760	2.00 hour

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026

A Study of LY3127760 in Healthy Participants

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Zero to Infinity (AUC 0-∞) of Single Dose LY3127760

PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC-tau (τ)] of Multiple Doses LY3127760

PK: Cmax of Multiple Doses LY3127760

PK: Maximum Observed Concentration (Cmax) of Single Dose LY3127760

PK: Time of Maximum Observed Concentration (Tmax) of Single Dose LY3127760

PK: Tmax of Multiple Doses LY3127760