Trial Outcomes & Findings for LY2189265 and Atorvastatin Interaction Study (NCT NCT01250834)
NCT ID: NCT01250834
Last Updated: 2014-10-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
Pre-dose to 56 hours post-dose
Results posted on
2014-10-08
Participant Flow
Participant milestones
| Measure |
LY2189265 + Atorvastatin
Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LY2189265 and Atorvastatin Interaction Study
Baseline characteristics by cohort
| Measure |
LY2189265 + Atorvastatin
n=27 Participants
Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
|
|---|---|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 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 Kingdom
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose to 56 hours post-dosePopulation: All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.
Outcome measures
| Measure |
40 mg Atorvastatin Alone
n=27 Participants
Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
|
1.5 mg LY2189265 + 40 mg Atorvastatin
n=27 Participants
Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
|
|---|---|---|
|
Pharmacokinetics of Atorvastatin: Maximum Plasma Concentration (Cmax)
|
19.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 60
|
5.78 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 86
|
PRIMARY outcome
Timeframe: Pre-dose to 56 hours post-dosePopulation: All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.
This measure is based on the pharmacokinetic area under the atorvastatin plasma concentration-time curve from time 0 to infinity.
Outcome measures
| Measure |
40 mg Atorvastatin Alone
n=27 Participants
Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
|
1.5 mg LY2189265 + 40 mg Atorvastatin
n=26 Participants
Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
|
|---|---|---|
|
Pharmacokinetics of Atorvastatin: Area Under the Curve (AUC)
|
82.8 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 33
|
65.9 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 35
|
SECONDARY outcome
Timeframe: Pre-dose to 56 hours post-dosePopulation: All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.
Outcome measures
| Measure |
40 mg Atorvastatin Alone
n=27 Participants
Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
|
1.5 mg LY2189265 + 40 mg Atorvastatin
n=26 Participants
Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
|
|---|---|---|
|
Pharmacokinetics of Para-Hydroxyatorvastatin: Maximum Concentration (Cmax)
|
0.473 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 81
|
0.360 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 69
|
SECONDARY outcome
Timeframe: Pre-dose to 56 hours post-dosePopulation: No participants were analyzed for this outcome measure since the terminal elimination phase was not determinable.
This measure is based on the pharmacokinetic area under the para-hydroxyatorvastatin concentration-time curve from time 0 to infinity. The outcome is not available for this metabolite since the terminal elimination phase was not determinable.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose to 56 hours post-dosePopulation: All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.
Outcome measures
| Measure |
40 mg Atorvastatin Alone
n=27 Participants
Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
|
1.5 mg LY2189265 + 40 mg Atorvastatin
n=27 Participants
Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
|
|---|---|---|
|
Pharmacokinetics of Ortho-Hydroxyatorvastatin: Maximum Concentration (Cmax)
|
14.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 46
|
5.66 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 60
|
SECONDARY outcome
Timeframe: Pre-dose to 56 hours post-dosePopulation: All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.
This measure is based on the pharmacokinetic area under the ortho-hydroxyatorvastatin concentration-time curve from time 0 to infinity.
Outcome measures
| Measure |
40 mg Atorvastatin Alone
n=27 Participants
Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
|
1.5 mg LY2189265 + 40 mg Atorvastatin
n=27 Participants
Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
|
|---|---|---|
|
Pharmacokinetics of Ortho-Hydroxyatorvastatin: Area Under the Curve (AUC)
|
102 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 30
|
95.9 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 28
|
Adverse Events
40 mg Atorvastatin Alone
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
1.5 mg LY2189265
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
1.5 mg LY2189265 + 40 mg Atorvastatin
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 |
40 mg Atorvastatin Alone
n=27 participants at risk
Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
|
1.5 mg LY2189265
n=27 participants at risk
Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3. The time period for this arm was from Day 1 to predose of atorvastatin on Day 3.
|
1.5 mg LY2189265 + 40 mg Atorvastatin
n=27 participants at risk
Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3. The time period for this arm was after the atorvastatin dose on Day 3 in Period 2.
|
|---|---|---|---|
|
Eye disorders
Eyelid oedema
|
0.00%
0/27
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/27
|
7.4%
2/27 • Number of events 2
|
0.00%
0/27
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/27
|
33.3%
9/27 • Number of events 10
|
3.7%
1/27 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/27
|
0.00%
0/27
|
11.1%
3/27 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Breath odour
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
0.00%
0/27
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
7.4%
2/27 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
3.7%
1/27 • Number of events 2
|
0.00%
0/27
|
0.00%
0/27
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
11.1%
3/27 • Number of events 5
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/27
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/27
|
33.3%
9/27 • Number of events 9
|
11.1%
3/27 • Number of events 4
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/27
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/27
|
14.8%
4/27 • Number of events 5
|
14.8%
4/27 • Number of events 4
|
|
General disorders
Fatigue
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
|
General disorders
Feeling hot
|
3.7%
1/27 • Number of events 1
|
7.4%
2/27 • Number of events 3
|
0.00%
0/27
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/27
|
0.00%
0/27
|
7.4%
2/27 • Number of events 2
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/27
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/27
|
44.4%
12/27 • Number of events 12
|
11.1%
3/27 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/27
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
0.00%
0/27
|
|
Nervous system disorders
Dizziness
|
0.00%
0/27
|
7.4%
2/27 • Number of events 2
|
0.00%
0/27
|
|
Nervous system disorders
Headache
|
0.00%
0/27
|
11.1%
3/27 • Number of events 3
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
Lethargy
|
0.00%
0/27
|
11.1%
3/27 • Number of events 3
|
0.00%
0/27
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/27
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
Presyncope
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/27
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/27
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/27
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/27
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.4%
2/27 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/27
|
3.7%
1/27 • Number of events 2
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
Needle track marks
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
0.00%
0/27
|
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