Trial Outcomes & Findings for A Study of Baricitinib When Administered With Ketoconazole or Fluconazole in Healthy Participants (NCT NCT01924299)
NCT ID: NCT01924299
Last Updated: 2017-06-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose
Results posted on
2017-06-06
Participant Flow
This was an open-label, 2-period, fixed-sequence study. Period 1 was from Day 1 through Day 2. Period 2 was from Day 3 through Day 9 for baricitinib + ketoconazole (Group A) and Day 3 through Day 10 for baricitinib + fluconazole (Group B).
Participant milestones
| Measure |
Baricitinib + Ketoconazole (Group A)
10 milligrams (mg) baricitinib administered orally once on Day 1 of Period 1 and on Day 6 of Period 2.
400 mg ketoconazole administered orally once daily (QD) for 6 days (Day 3 through Day 8) in Period 2.
|
Baricitinib + Fluconazole (Group B)
10 mg baricitinib administered orally once on Day 1 of Period 1 and on Day 7 of Period 2.
400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2.
|
|---|---|---|
|
Period 1
STARTED
|
18
|
18
|
|
Period 1
Received Baricitinib
|
18
|
18
|
|
Period 1
COMPLETED
|
18
|
18
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
18
|
18
|
|
Period 2
Received at Least 1 Dose of Study Drug
|
18
|
18
|
|
Period 2
Received Baricitinib
|
17
|
17
|
|
Period 2
COMPLETED
|
17
|
17
|
|
Period 2
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Baricitinib + Ketoconazole (Group A)
10 milligrams (mg) baricitinib administered orally once on Day 1 of Period 1 and on Day 6 of Period 2.
400 mg ketoconazole administered orally once daily (QD) for 6 days (Day 3 through Day 8) in Period 2.
|
Baricitinib + Fluconazole (Group B)
10 mg baricitinib administered orally once on Day 1 of Period 1 and on Day 7 of Period 2.
400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2.
|
|---|---|---|
|
Period 2
Withdrawal by Subject
|
1
|
0
|
|
Period 2
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Study of Baricitinib When Administered With Ketoconazole or Fluconazole in Healthy Participants
Baseline characteristics by cohort
| Measure |
Baricitinib + Ketoconazole (Group A)
n=18 Participants
10 mg baricitinib administered orally once on Day 1 of Period 1 and on Day 6 of Period 2.
400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2.
|
Baricitinib + Fluconazole (Group B)
n=18 Participants
10 mg baricitinib administered orally once on Day 1 of Period 1 and on Day 7 of Period 2.
400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
42.7 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
42.5 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdosePopulation: All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ketoconazole in Period 2) and had PK data to calculate AUC(0-∞) of baricitinib.
Outcome measures
| Measure |
Baricitinib (Group A)
n=18 Participants
10 mg baricitinib administered orally once on Day 1 of Period 1.
|
Baricitinib + Ketoconazole (Group A)
n=17 Participants
10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2.
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole
|
720 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 23
|
868 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 24
|
PRIMARY outcome
Timeframe: Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdosePopulation: All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + fluconazole in Period 2) and had PK data to calculate AUC(0-∞) of baricitinib.
Outcome measures
| Measure |
Baricitinib (Group A)
n=18 Participants
10 mg baricitinib administered orally once on Day 1 of Period 1.
|
Baricitinib + Ketoconazole (Group A)
n=17 Participants
10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2.
|
|---|---|---|
|
PK: AUC(0-∞) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole
|
698 ng*h/mL
Geometric Coefficient of Variation 24
|
851 ng*h/mL
Geometric Coefficient of Variation 24
|
PRIMARY outcome
Timeframe: Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdosePopulation: All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ketoconazole in Period 2) and had PK data to calculate Cmax of baricitinib.
Outcome measures
| Measure |
Baricitinib (Group A)
n=18 Participants
10 mg baricitinib administered orally once on Day 1 of Period 1.
|
Baricitinib + Ketoconazole (Group A)
n=17 Participants
10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2.
|
|---|---|---|
|
PK: Maximum Concentration (Cmax) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole
|
106 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 27
|
115 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
PRIMARY outcome
Timeframe: Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdosePopulation: All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + fluconazole in Period 2) and had PK data to calculate Cmax of baricitinib.
Outcome measures
| Measure |
Baricitinib (Group A)
n=18 Participants
10 mg baricitinib administered orally once on Day 1 of Period 1.
|
Baricitinib + Ketoconazole (Group A)
n=17 Participants
10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2.
|
|---|---|---|
|
PK: Cmax of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole
|
103 ng/mL
Geometric Coefficient of Variation 36
|
107 ng/mL
Geometric Coefficient of Variation 38
|
PRIMARY outcome
Timeframe: Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdosePopulation: All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ketoconazole in Period 2) and had PK data to calculate Tmax of baricitinib.
Outcome measures
| Measure |
Baricitinib (Group A)
n=18 Participants
10 mg baricitinib administered orally once on Day 1 of Period 1.
|
Baricitinib + Ketoconazole (Group A)
n=17 Participants
10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2.
|
|---|---|---|
|
PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole
|
1.00 hours
Interval 0.5 to 2.0
|
1.00 hours
Interval 0.5 to 2.0
|
PRIMARY outcome
Timeframe: Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdosePopulation: All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + fluconazole in Period 2) and had PK data to calculate Tmax of baricitinib.
Outcome measures
| Measure |
Baricitinib (Group A)
n=18 Participants
10 mg baricitinib administered orally once on Day 1 of Period 1.
|
Baricitinib + Ketoconazole (Group A)
n=17 Participants
10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2.
|
|---|---|---|
|
PK: Tmax of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole
|
1.00 hours
Interval 0.5 to 4.0
|
1.00 hours
Interval 0.5 to 3.0
|
Adverse Events
Baricitinib (Group A)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Ketoconazole (Group A)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Baricitinib + Ketoconazole (Group A)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Baricitinib (Group B)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Fluconazole (Group B)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Baricitinib + Fluconazole (Group B)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Baricitinib (Group A)
n=18 participants at risk
10 mg baricitinib administered orally once on Day 1 of Period 1. Adverse events are reported from baseline through predose on Day 3.
|
Ketoconazole (Group A)
n=18 participants at risk
400 mg ketoconazole administered orally QD on Day 3 through Day 5 in Period 2. Adverse events are reported from postdose on Day 3 through predose on Day 6.
|
Baricitinib + Ketoconazole (Group A)
n=17 participants at risk
10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg ketoconazole administered orally QD on Day 6 through Day 8 in Period 2.
Adverse events are reported from postdose on Day 6 up to Day 22.
|
Baricitinib (Group B)
n=18 participants at risk
10 mg baricitinib administered orally once on Day 1 of Period 1. Adverse events are reported from baseline through predose on Day 3.
|
Fluconazole (Group B)
n=18 participants at risk
400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD on Day 4 through Day 6 in Period 2.
Adverse events are reported from postdose on Day 3 through predose on Day 7.
|
Baricitinib + Fluconazole (Group B)
n=17 participants at risk
10 mg baricitinib administered orally once on Day 7 of Period 2. 200 mg fluconazole administered orally QD on Day 7 through Day 9 in Period 2. Adverse events are reported from postdose on Day 7 up to Day 23.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Vision blurred
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
11.1%
2/18 • Number of events 2 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
|
General disorders
Catheter site related reaction
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
5.9%
1/17 • Number of events 1 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
5.9%
1/17 • Number of events 1 • Baseline through study completion (up to Day 23).
|
|
General disorders
Influenza like illness
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
5.9%
1/17 • Number of events 1 • Baseline through study completion (up to Day 23).
|
|
General disorders
Pain
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
5.9%
1/17 • Number of events 1 • Baseline through study completion (up to Day 23).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 23).
|
5.9%
1/17 • Number of events 1 • Baseline through study completion (up to Day 23).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
5.9%
1/17 • Number of events 1 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
|
Nervous system disorders
Headache
|
16.7%
3/18 • Number of events 3 • Baseline through study completion (up to Day 23).
|
33.3%
6/18 • Number of events 7 • Baseline through study completion (up to Day 23).
|
11.8%
2/17 • Number of events 3 • Baseline through study completion (up to Day 23).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
5.9%
1/17 • Number of events 1 • Baseline through study completion (up to Day 23).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
5.9%
1/17 • Number of events 1 • Baseline through study completion (up to Day 23).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
5.9%
1/17 • Number of events 2 • Baseline through study completion (up to Day 23).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
5.9%
1/17 • Number of events 1 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/17 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
0.00%
0/18 • Baseline through study completion (up to Day 23).
|
5.9%
1/17 • Number of events 1 • Baseline through study completion (up to Day 23).
|
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