CompletedNCT01536951Updated Jun 6, 2017Results posted

A Study of LY3009104 in Healthy Participants

A Phase 1 interventional study of LY3009104 and Placebo in Healthy Participants, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-06.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 62
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

This will be a 2-part, randomized, participant- and investigator-blind study in healthy males and females.

Part A of this study is to determine a safe and tolerable single oral dose of LY3009104 that yields drug exposures slightly exceeding typical exposures anticipated from repeated administration of an efficacious dose to participants. The concentration of the drug in the blood stream will be measured and information about any side effects that may occur will also be collected.

Part B of this study is to evaluate the effect of LY3009104 on the electrical activity of the heart as measured by electrocardiogram (ECG) in relation to placebo following a single oral dose.

Conditions studied

Healthy Participants

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Are overtly healthy males or females as determined by medical history and physical examination. Are drug free, disease free, and no cardiac abnormalities.
Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
Have a clinically normal screening ECG with a measurable QT interval as judged by the investigator, and which in Part B allows accurate measurements of QT interval.

Exclusion criteria

Exclusion Criteria:

Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
Have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study or affects or confounds the corrected QT (QTc) analysis or have QTc greater than 450 milliseconds (msec).
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening.

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 62 participants (actual)

Study arms

Placebo comparator
Placebo
Placebo matching LY3009104 tablets in size and appearance will be administered orally in 1 out of 3 study periods in Part A and Part B.
Drug: Placebo
Experimental
LY3009104
Part A. Single escalating dose of up to 40 milligrams (mg) of LY3009104 administered orally in 2 out of 3 study periods separated by at least a 3 day wash-out period between each dose. Part B. Single dose of LY3009104 determined in Part A administered orally in 1 out of 3 study periods separated by at least a 3 day wash-out period between each period.
Drug: LY3009104
Active comparator
400 mg moxifloxacin
Part B. 400 mg moxifloxacin will be administered orally in 1 out of 3 study periods separated by at least a 3 day wash-out period between each period.
Drug: moxifloxacin

Interventions

DrugLY3009104
administered orally
Also known as: Baricitinib
DrugPlacebo
Administered orally
Drugmoxifloxacin
Administered orally

What researchers measure

Primary outcomes

Change From Baseline Through 24 Hours Postdose in Population-Corrected QT (QTcP) Interval
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using the population-corrected formula: QTcP = QT/RR\^beta, where beta is the population correction factor computed from a log-linear model (ln) QT = alpha+beta\*ln RR fitted to all Day -1 and Day 1 predose QT and RR measurements in all periods for all participants. Baseline is the average of data collected for 2 hours before dosing on Day 1 of each period \[-2 hours (h), -1.5 h, -1 h, -0.5 h, and 0 h\]. The QTcP interval was not assessed during Part A of the study, as specified in the protocol. The QTcP interval at 1 h, 2 h, and 4 h postdose for moxifloxacin was compared to placebo to establish assay sensitivity.
Time frame: Part B, Periods 1 through 3: Baseline, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, and 24 h postdose
Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104
Time frame: Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drug
Pharmacokinetics: Area Under the Concentration Curve From Time 0 to Infinity [AUC(0-inf)] of LY3009104
Time frame: Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drug
Number of Participants With 1 or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)
The number of participants with treatment-emergent adverse events (TEAEs) or treatment-emergent SAEs considered by the investigator to be related to study drug is reported. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Time frame: Baseline through study completion and 30-day follow-up

Results

Posted Apr 21, 2017

Participant flow

First Intervention and Washout Period 1

Participant flow — First Intervention and Washout Period 1
Milestone	Part A: Placebo, 30 mg LY3009104, 40 mg LY3009104	Part A: 20 mg LY3009104, 30 mg LY3009104, Placebo	Part A: 20 mg LY3009104, Placebo, 40 mg LY3009104	Part B: 40 mg LY3009104, Placebo, Moxifloxacin	Part B: Placebo, Moxifloxacin, 40 mg LY3009104	Part B: Moxifloxacin, 40 mg LY3009104, Placebo	Part B: Moxifloxacin, Placebo, 40 mg LY3009104	Part B: 40 mg LY3009104, Moxifloxacin, Placebo	Part B: Placebo, 40 mg LY3009104, Moxifloxacin
Started	3	3	3	8	9	9	9	9	9
Received at least 1 dose of study drug	3	3	3	8	9	9	9	9	9
Completed	3	3	2	8	9	9	9	9	9
Not completed	0	0	1	0	0	0	0	0	0
Withdrew: Withdrawal by subject	0	0	1	0	0	0	0	0	0

Second Intervention and Washout Period 2

Participant flow — Second Intervention and Washout Period 2
Milestone	Part A: Placebo, 30 mg LY3009104, 40 mg LY3009104	Part A: 20 mg LY3009104, 30 mg LY3009104, Placebo	Part A: 20 mg LY3009104, Placebo, 40 mg LY3009104	Part B: 40 mg LY3009104, Placebo, Moxifloxacin	Part B: Placebo, Moxifloxacin, 40 mg LY3009104	Part B: Moxifloxacin, 40 mg LY3009104, Placebo	Part B: Moxifloxacin, Placebo, 40 mg LY3009104	Part B: 40 mg LY3009104, Moxifloxacin, Placebo	Part B: Placebo, 40 mg LY3009104, Moxifloxacin
Started	3	3	2	8	9	9	9	9	9
Completed	3	3	2	8	9	9	9	8	9
Not completed	0	0	0	0	0	0	0	1	0
Withdrew: Adverse event	0	0	0	0	0	0	0	1	0

Third Intervention

Participant flow — Third Intervention
Milestone	Part A: Placebo, 30 mg LY3009104, 40 mg LY3009104	Part A: 20 mg LY3009104, 30 mg LY3009104, Placebo	Part A: 20 mg LY3009104, Placebo, 40 mg LY3009104	Part B: 40 mg LY3009104, Placebo, Moxifloxacin	Part B: Placebo, Moxifloxacin, 40 mg LY3009104	Part B: Moxifloxacin, 40 mg LY3009104, Placebo	Part B: Moxifloxacin, Placebo, 40 mg LY3009104	Part B: 40 mg LY3009104, Moxifloxacin, Placebo	Part B: Placebo, 40 mg LY3009104, Moxifloxacin
Started	3	3	2	8	9	9	9	8	9
Completed	3	3	2	8	9	9	9	8	9
Not completed	0	0	0	0	0	0	0	0	0

Outcome measures

PrimaryChange From Baseline Through 24 Hours Postdose in Population-Corrected QT (QTcP) Interval

The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using the population-corrected formula: QTcP = QT/RR\^beta, where beta is the population correction factor computed from a log-linear model (ln) QT = alpha+beta\*ln RR fitted to all Day -1 and Day 1 predose QT and RR measurements in all periods for all participants. Baseline is the average of data collected for 2 hours before dosing on Day 1 of each period \[-2 hours (h), -1.5 h, -1 h, -0.5 h, and 0 h\]. The QTcP interval was not assessed during Part A of the study, as specified in the protocol. The QTcP interval at 1 h, 2 h, and 4 h postdose for moxifloxacin was compared to placebo to establish assay sensitivity.

Time frame:: Part B, Periods 1 through 3: Baseline, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, and 24 h postdose
Reported as:: Mean · milliseconds (msec)

Change From Baseline Through 24 Hours Postdose in Population-Corrected QT (QTcP) Interval
milliseconds (msec)	Part B: Placebo	Part B: 40 mg LY3009104	Part B: Moxifloxacin
1 h postdose (n=52, 53, 53)	-2.5 ± 4.9	-2.4 ± 5.0	9.7 ± 5.8
1.5 h postdose (n=52, 53, 53)	-1.7 ± 3.9	0.1 ± 5.5	9.3 ± 5.8
2 h postdose (n=52, 53, 53)	-1.4 ± 6.5	-0.1 ± 5.3	9.5 ± 6.9
3 h postdose (n=52, 53, 53)	-2.8 ± 5.7	-2.5 ± 4.9	9.2 ± 6.2
4 h postdose (n=52, 53, 53)	-1.3 ± 5.2	-0.8 ± 6.2	9.9 ± 5.5
6 h postdose (n=51, 53, 53)	-1.3 ± 8.3	-2.2 ± 8.1	5.5 ± 7.3
12 h postdose (n=52, 52, 52)	-1.0 ± 8.3	0.8 ± 6.6	5.9 ± 7.6
24 h postdose (n=52, 53, 53)	-1.6 ± 6.1	-0.8 ± 6.7	3.4 ± 5.5

Statistical analysis

Part B: Placebo vs Part B: 40 mg LY3009104 · Least squares (ls) mean difference: 0.239 · 90% CI -1.65 to 2.12LS mean difference (LY3009104 minus placebo) of change in QTcP 1 h postdose analyzed using analysis of covariance (ANCOVA) model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.
Part B: Placebo vs Part B: 40 mg LY3009104 · Ls mean difference: 1.81 · 90% CI -0.0790 to 3.69LS mean difference (LY3009104 minus placebo) of change in QTcP at 1.5 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.
Part B: Placebo vs Part B: 40 mg LY3009104 · Ls mean difference: 1.44 · 90% CI -0.446 to 3.32LS mean difference (LY3009104 minus placebo) of change in QTcP at 2 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.
Part B: Placebo vs Part B: 40 mg LY3009104 · Ls mean difference: 0.468 · 90% CI -1.42 to 2.35LS mean difference (LY3009104 minus placebo) of change in QTcP at 3 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.
Part B: Placebo vs Part B: 40 mg LY3009104 · Ls mean difference: 0.702 · 90% CI -1.18 to 2.59LS mean difference (LY3009104 minus placebo) of change in QTcP at 4 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.
Part B: Placebo vs Part B: 40 mg LY3009104 · Ls mean difference: -0.788 · 90% CI -2.68 to 1.10LS mean difference (LY3009104 minus placebo) of change in QTcP at 6 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.
Part B: Placebo vs Part B: 40 mg LY3009104 · Ls mean difference: 1.71 · 90% CI -0.182 to 3.60LS mean difference (LY3009104 minus placebo) of change in QTcP at 12 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.
Part B: Placebo vs Part B: 40 mg LY3009104 · Ls mean difference: 0.963 · 90% CI -0.921 to 2.85LS mean difference (LY3009104 minus placebo) of change in QTcP at 24 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.
Part B: Placebo vs Part B: Moxifloxacin · Ls mean difference: 12.3 · 90% CI 10.0 to 14.5LS mean difference (moxifloxacin minus placebo) of change in QTcP at 1 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.
Part B: Placebo vs Part B: Moxifloxacin · Ls mean difference: 11.0 · 90% CI 8.74 to 13.3LS mean difference (moxifloxacin minus placebo) of change in QTcP at 2 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.
Part B: Placebo vs Part B: Moxifloxacin · Ls mean difference: 11.1 · 90% CI 8.87 to 13.4LS mean difference (moxifloxacin minus placebo) of change in QTcP at 4 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.

PrimaryPharmacokinetics: Maximum Concentration (Cmax) of LY3009104

Time frame:: Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drug
Reported as:: Geometric mean · nanomoles per liter (nmol/L)

Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104
nanomoles per liter (nmol/L)	Part A: 20 mg LY3009104	Part A: 30 mg LY3009104	Part A: 40 mg LY3009104	Part B: 40 mg LY3009104
Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104	578 ± 28	734 ± 14	1270 ± 13	741 ± 33

PrimaryPharmacokinetics: Area Under the Concentration Curve From Time 0 to Infinity [AUC(0-inf)] of LY3009104

Time frame:: Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drug
Reported as:: Geometric mean · hours*nanomoles per liter (h*nmol/L)

Pharmacokinetics: Area Under the Concentration Curve From Time 0 to Infinity [AUC(0-inf)] of LY3009104
hoursnanomoles per liter (hnmol/L)	Part A: 20 mg LY3009104	Part A: 30 mg LY3009104	Part A: 40 mg LY3009104	Part B: 40 mg LY3009104
Pharmacokinetics: Area Under the Concentration Curve From Time 0 to Infinity [AUC(0-inf)] of LY3009104	3960 ± 27	5480 ± 19	8490 ± 14	6440 ± 26

PrimaryNumber of Participants With 1 or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)

The number of participants with treatment-emergent adverse events (TEAEs) or treatment-emergent SAEs considered by the investigator to be related to study drug is reported. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.

Time frame:: Baseline through study completion and 30-day follow-up
Reported as:: Count of participants · Participants

Number of Participants With 1 or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)
Participants	Part A: Placebo	Part A: 20 mg LY3009104	Part A: 30 mg LY3009104	Part A: 40 mg LY3009104	Part B: Placebo	Part B: 40 mg LY3009104	Part B: Moxifloxacin
Drug-Related TEAE	0	0	1	0	5	5	5
Drug-Related SAE	0	0	0	0	0	0	0

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Part A: Placebo	—	0/8 (0%)	2/8 (25%)
Part A: 20 mg LY3009104	—	0/6 (0%)	1/6 (16.7%)
Part A: 30 mg LY3009104	—	0/6 (0%)	2/6 (33.3%)
Part A: 40 mg LY3009104	—	0/5 (0%)	0/5 (0%)
Part B: Placebo	—	0/52 (0%)	8/52 (15.4%)
Part B: 40 mg LY3009104	—	0/53 (0%)	6/53 (11.3%)
Part B: Moxifloxacin	—	0/53 (0%)	7/53 (13.2%)

Most frequent other events

Showing 10 of 32

Most frequent other events
Event	Part A: Placebo	Part A: 20 mg LY3009104	Part A: 30 mg LY3009104	Part A: 40 mg LY3009104	Part B: Placebo	Part B: 40 mg LY3009104	Part B: Moxifloxacin
Procedural site reactionInjury, poisoning and procedural complications	0/8	1/6	0/6	0/5	0/52	0/53	0/53
Muscle tightnessMusculoskeletal and connective tissue disorders	0/8	0/6	1/6	0/5	0/52	0/53	0/53
Muscle twitchingMusculoskeletal and connective tissue disorders	0/8	0/6	1/6	0/5	0/52	0/53	0/53
HeadacheNervous system disorders	0/8	0/6	1/6	0/5	1/52	2/53	1/53
CoughRespiratory, thoracic and mediastinal disorders	0/8	0/6	1/6	0/5	1/52	0/53	0/53
Increased upper airway secretionRespiratory, thoracic and mediastinal disorders	0/8	0/6	1/6	0/5	0/52	0/53	0/53
Oropharyngeal painRespiratory, thoracic and mediastinal disorders	0/8	0/6	1/6	0/5	1/52	0/53	0/53
Respiratory tract congestionRespiratory, thoracic and mediastinal disorders	1/8	0/6	1/6	0/5	0/52	0/53	0/53
Dermatitis contactSkin and subcutaneous tissue disorders	1/8	0/6	0/6	0/5	0/52	0/53	0/53
DiarrhoeaGastrointestinal disorders	0/8	0/6	0/6	0/5	3/52	2/53	4/53

Baseline characteristics

Participants who received at least 1 dose of LY3009104, moxifloxacin, or placebo and had at least 1 postdose safety assessment.

Age, Continuous
Age, Continuous(years)	Part A (LY3009104 or Placebo)	Part B (LY3009104, Moxifloxacin, or Placebo)	Total
Mean	45.9 ± 15.4	39.9 ± 11.3	40.8 ± 12.0

Sex: Female, Male
Sex: Female, Male(Participants)	Part A (LY3009104 or Placebo)	Part B (LY3009104, Moxifloxacin, or Placebo)	Total
Female	4	10	14
Male	5	43	48

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Part A (LY3009104 or Placebo)	Part B (LY3009104, Moxifloxacin, or Placebo)	Total
Hispanic or Latino	3	21	24
Not Hispanic or Latino	6	32	38
Unknown or Not Reported	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Part A (LY3009104 or Placebo)	Part B (LY3009104, Moxifloxacin, or Placebo)	Total
Black or African American	1	12	13
White	8	39	47
More than 1 race	0	2	2

Region of Enrollment
Region of Enrollment(Participants)	Part A (LY3009104 or Placebo)	Part B (LY3009104, Moxifloxacin, or Placebo)	Total
United States	9	53	62

Study locations

1 site

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.
Daytona Beach, Florida 32117, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01536951
Lead sponsor: Eli Lilly and Company
Collaborators: Incyte Corporation
Responsible party: Sponsor
First posted: Feb 22, 2012
Start date: Feb 2012
Primary completion: May 2013
Completion: May 2013
Results posted: Apr 21, 2017
Last update: Jun 6, 2017

Study contacts

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)

study director · Eli Lilly and Company

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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