Trial Outcomes & Findings for A Study of LY2216684 in Participants With Impaired Hepatic Function (NCT NCT01241435)
NCT ID: NCT01241435
Last Updated: 2018-10-22
Results Overview
The area under the plasma concentration versus time curve from 0 hours to infinity (AUC \[0-∞\]) for LY2216684 is presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Up to 72 hours after administration of study drug
Results posted on
2018-10-22
Participant Flow
Participant milestones
| Measure |
Normal Hepatic Function
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function
|
Mild Hepatic Impairment
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with mild hepatic impairment (Child-Pugh A)
|
Moderate Hepatic Impairment
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with moderate hepatic impairment (Child-Pugh B)
|
Severe Hepatic Impairment
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with severe hepatic impairment (Child-Pugh C)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
8
|
8
|
8
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
12
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
12
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LY2216684 in Participants With Impaired Hepatic Function
Baseline characteristics by cohort
| Measure |
Normal Hepatic Function
n=12 Participants
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function
|
Mild Hepatic Impairment
n=8 Participants
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with mild hepatic impairment (Child-Pugh A)
|
Moderate Hepatic Impairment
n=8 Participants
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with moderate hepatic impairment (Child-Pugh B)
|
Severe Hepatic Impairment
n=8 Participants
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with severe hepatic impairment (Child-Pugh C)
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
54.5 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 6.9 • n=4 Participants
|
52.3 years
STANDARD_DEVIATION 6.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 72 hours after administration of study drugPopulation: Participants who received at least one dose of study drug.
The area under the plasma concentration versus time curve from 0 hours to infinity (AUC \[0-∞\]) for LY2216684 is presented.
Outcome measures
| Measure |
Normal Hepatic Function
n=12 Participants
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function
|
Mild Hepatic Impairment
n=8 Participants
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with mild hepatic impairment (Child-Pugh A)
|
Moderate Hepatic Impairment
n=8 Participants
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with moderate hepatic impairment (Child-Pugh B)
|
Severe Hepatic Impairment
n=8 Participants
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with severe hepatic impairment (Child-Pugh C)
|
|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Curve (AUC)
|
601 hours times nanograms/milliliter
Geometric Coefficient of Variation 32 • Interval 503.0 to 717.0
|
742 hours times nanograms/milliliter
Geometric Coefficient of Variation 52 • Interval 598.0 to 922.0
|
961 hours times nanograms/milliliter
Geometric Coefficient of Variation 45 • Interval 774.0 to 1194.0
|
1020 hours times nanograms/milliliter
Geometric Coefficient of Variation 16 • Interval 820.0 to 1265.0
|
PRIMARY outcome
Timeframe: Up to 72 hours after administration of study drugPopulation: Participants who received at least one dose of study drug.
Outcome measures
| Measure |
Normal Hepatic Function
n=12 Participants
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function
|
Mild Hepatic Impairment
n=8 Participants
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with mild hepatic impairment (Child-Pugh A)
|
Moderate Hepatic Impairment
n=8 Participants
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with moderate hepatic impairment (Child-Pugh B)
|
Severe Hepatic Impairment
n=8 Participants
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with severe hepatic impairment (Child-Pugh C)
|
|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax)
|
46.8 nanograms/milliliter
Geometric Coefficient of Variation 27
|
39.6 nanograms/milliliter
Geometric Coefficient of Variation 28
|
41.9 nanograms/milliliter
Geometric Coefficient of Variation 33
|
34.7 nanograms/milliliter
Geometric Coefficient of Variation 15
|
PRIMARY outcome
Timeframe: Up to 72 hours after administration of study drugPopulation: Participants who received at least one dose of study drug.
Outcome measures
| Measure |
Normal Hepatic Function
n=12 Participants
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function
|
Mild Hepatic Impairment
n=8 Participants
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with mild hepatic impairment (Child-Pugh A)
|
Moderate Hepatic Impairment
n=8 Participants
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with moderate hepatic impairment (Child-Pugh B)
|
Severe Hepatic Impairment
n=8 Participants
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with severe hepatic impairment (Child-Pugh C)
|
|---|---|---|---|---|
|
Pharmacokinetics: Time to Maximum Concentration (Tmax)
|
3.00 hours
Interval 1.0 to 5.0
|
3.50 hours
Interval 2.0 to 6.0
|
3.50 hours
Interval 1.0 to 5.0
|
3.50 hours
Interval 2.0 to 5.0
|
Adverse Events
Normal Hepatic Function
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Mild Hepatic Impairment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Moderate Hepatic Impairment
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Severe Hepatic Impairment
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Normal Hepatic Function
n=12 participants at risk
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function
|
Mild Hepatic Impairment
n=8 participants at risk
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with mild hepatic impairment (Child-Pugh A)
|
Moderate Hepatic Impairment
n=8 participants at risk
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with moderate hepatic impairment (Child-Pugh B)
|
Severe Hepatic Impairment
n=8 participants at risk
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with severe hepatic impairment (Child-Pugh C)
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/12
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
|
Eye disorders
Blepharitis
|
0.00%
0/12
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Eye disorders
Vision blurred
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Number of events 2
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Fatigue
|
0.00%
0/12
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Feeling abnormal
|
0.00%
0/12
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
1/12 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Nervous system disorders
Dizziness
|
25.0%
3/12 • Number of events 3
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/12
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Nervous system disorders
Headache
|
0.00%
0/12
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Renal and urinary disorders
Micturition urgency
|
8.3%
1/12 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Renal and urinary disorders
Urinary hesitation
|
8.3%
1/12 • Number of events 1
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
1/12 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.3%
1/12 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60