Trial Outcomes & Findings for A Study of the Effect of Dulaglutide on How Body Handles Digoxin in Healthy Participants (NCT NCT01436201)
NCT ID: NCT01436201
Last Updated: 2014-10-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17
Results posted on
2014-10-07
Participant Flow
Participant milestones
| Measure |
Digoxin + Dulaglutide
Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 17.
Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
24
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Digoxin + Dulaglutide
Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 17.
Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
A Study of the Effect of Dulaglutide on How Body Handles Digoxin in Healthy Participants
Baseline characteristics by cohort
| Measure |
Digoxin + Dulaglutide
n=24 Participants
Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 17.
Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15.
|
|---|---|
|
Age, Continuous
|
43.4 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17Population: Participants who received at least one dose of study drug (digoxin or dulaglutide) with evaluable digoxin AUC data.
Outcome measures
| Measure |
Digoxin Only
n=21 Participants
Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7.
|
Digoxin + Dulaglutide
n=21 Participants
Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17.
Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15.
|
|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Digoxin
Day 7
|
16.8 nanograms times hours/milliliter
Geometric Coefficient of Variation 25
|
NA nanograms times hours/milliliter
Geometric Coefficient of Variation NA
Participants had not received dulaglutide dose at Day 7.
|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Digoxin
Day 10
|
NA nanograms times hours/milliliter
Geometric Coefficient of Variation NA
Participants received digoxin + dulaglutide dose at Day 10 (not digoxin only).
|
16.1 nanograms times hours/milliliter
Geometric Coefficient of Variation 26
|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Digoxin
Day 17 (n=20)
|
NA nanograms times hours/milliliter
Geometric Coefficient of Variation NA
Participants received digoxin + dulaglutide dose at Day 17 (not digoxin only).
|
16.3 nanograms times hours/milliliter
Geometric Coefficient of Variation 32
|
PRIMARY outcome
Timeframe: Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17Population: Participants who received at least one dose of study drug (digoxin or dulaglutide) with evaluable digoxin Cmax data.
Outcome measures
| Measure |
Digoxin Only
n=21 Participants
Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7.
|
Digoxin + Dulaglutide
n=21 Participants
Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17.
Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15.
|
|---|---|---|
|
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Digoxin
Day 7
|
1.71 nanograms per milliliter
Geometric Coefficient of Variation 27
|
NA nanograms per milliliter
Geometric Coefficient of Variation NA
Participants had not received dulaglutide dose at Day 7.
|
|
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Digoxin
Day 10
|
NA nanograms per milliliter
Geometric Coefficient of Variation NA
Participants received digoxin + dulaglutide dose at Day 10 (not digoxin only).
|
1.34 nanograms per milliliter
Geometric Coefficient of Variation 40
|
|
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Digoxin
Day 17 (n=20)
|
NA nanograms per milliliter
Geometric Coefficient of Variation NA
Participants received digoxin + dulaglutide dose at Day 17 (not digoxin only).
|
1.42 nanograms per milliliter
Geometric Coefficient of Variation 42
|
PRIMARY outcome
Timeframe: Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17Population: Participants who received at least one dose of study drug (digoxin or dulaglutide) with evaluable digoxin Tmax data.
Outcome measures
| Measure |
Digoxin Only
n=21 Participants
Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7.
|
Digoxin + Dulaglutide
n=21 Participants
Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17.
Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15.
|
|---|---|---|
|
Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin
Day 7
|
1.00 hours
Interval 0.5 to 1.5
|
NA hours
Participants had not received dulaglutide dose at Day 7.
|
|
Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin
Day 10
|
NA hours
Participants received digoxin + dulaglutide dose at Day 10 (not digoxin only).
|
1.50 hours
Interval 1.0 to 6.0
|
|
Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin
Day 17 (n=20)
|
NA hours
Participants received digoxin + dulaglutide dose at Day 17 (not digoxin only).
|
1.50 hours
Interval 1.0 to 4.0
|
Adverse Events
Digoxin
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Digoxin + Dulaglutide
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Digoxin
n=24 participants at risk
Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7.
|
Digoxin + Dulaglutide
n=21 participants at risk
Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17.
Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15.
|
|---|---|---|
|
Cardiac disorders
Atrioventricular block first degree
|
16.7%
4/24 • Number of events 5
|
28.6%
6/21 • Number of events 6
|
|
Cardiac disorders
Palpitations
|
0.00%
0/24
|
9.5%
2/21 • Number of events 2
|
|
Cardiac disorders
Ventricular extrasystoles
|
4.2%
1/24 • Number of events 1
|
0.00%
0/21
|
|
Eye disorders
Blepharospasm
|
0.00%
0/24
|
4.8%
1/21 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/24
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
4.2%
1/24 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
2/24 • Number of events 2
|
0.00%
0/21
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/24
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
1/24 • Number of events 1
|
9.5%
2/21 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/24
|
9.5%
2/21 • Number of events 2
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/24
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.2%
1/24 • Number of events 1
|
33.3%
7/21 • Number of events 9
|
|
Gastrointestinal disorders
Nausea
|
8.3%
2/24 • Number of events 2
|
28.6%
6/21 • Number of events 7
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/24
|
14.3%
3/21 • Number of events 3
|
|
General disorders
Chest discomfort
|
4.2%
1/24 • Number of events 1
|
0.00%
0/21
|
|
General disorders
Feeling cold
|
0.00%
0/24
|
4.8%
1/21 • Number of events 2
|
|
General disorders
Feeling hot
|
0.00%
0/24
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/24
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/24
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Vessel puncture site reaction
|
0.00%
0/24
|
4.8%
1/21 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
0.00%
0/24
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/24
|
4.8%
1/21 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/24
|
14.3%
3/21 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
0.00%
0/24
|
4.8%
1/21 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.2%
1/24 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/24
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/24
|
9.5%
2/21 • Number of events 2
|
|
Nervous system disorders
Headache
|
0.00%
0/24
|
28.6%
6/21 • Number of events 11
|
|
Psychiatric disorders
Anxiety
|
4.2%
1/24 • Number of events 1
|
0.00%
0/21
|
|
Psychiatric disorders
Insomnia
|
4.2%
1/24 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.2%
1/24 • Number of events 1
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/24
|
4.8%
1/21 • Number of events 1
|
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