Trial Outcomes & Findings for A Study of Evacetrapib in Healthy Female Participants (NCT NCT01746732)
NCT ID: NCT01746732
Last Updated: 2018-10-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
Results posted on
2018-10-09
Participant Flow
Participant milestones
| Measure |
Ortho-Cyclen
Ortho-Cyclen (OC) of (35 microgram \[mcg\] ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD) for 28 days (Days 1 to 28)
|
Ortho-Cyclen Then Ortho-Cyclen + Evacetrapib; Sequence AB
Treatment A OC administered orally, QD for 28 days (Days 1 to 28)
Treatment B OC administered orally, QD for 28 days (Days 1 to 28) and 130 milligram (mg) Evacetrapib orally, QD for 21 days (Days 1 to 21)
|
Ortho-Cyclen + Evacetrapib Then Ortho-Cyclen; Sequence BA
Treatment B OC administered orally, QD for 28 days (Days 1 to 28) and 130 mg Evacetrapib orally, QD for 21 days (Days 1 to 21)
Treatment A OC administered orally, QD for 28 days (Days 1 to 28)
|
|---|---|---|---|
|
Lead-In Period
STARTED
|
23
|
0
|
0
|
|
Lead-In Period
Participants Received at Least 1 Dose
|
22
|
0
|
0
|
|
Lead-In Period
COMPLETED
|
22
|
0
|
0
|
|
Lead-In Period
NOT COMPLETED
|
1
|
0
|
0
|
|
Period 1
STARTED
|
0
|
11
|
11
|
|
Period 1
COMPLETED
|
0
|
10
|
11
|
|
Period 1
NOT COMPLETED
|
0
|
1
|
0
|
|
Period 2
STARTED
|
0
|
10
|
11
|
|
Period 2
COMPLETED
|
0
|
10
|
7
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
4
|
Reasons for withdrawal
| Measure |
Ortho-Cyclen
Ortho-Cyclen (OC) of (35 microgram \[mcg\] ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD) for 28 days (Days 1 to 28)
|
Ortho-Cyclen Then Ortho-Cyclen + Evacetrapib; Sequence AB
Treatment A OC administered orally, QD for 28 days (Days 1 to 28)
Treatment B OC administered orally, QD for 28 days (Days 1 to 28) and 130 milligram (mg) Evacetrapib orally, QD for 21 days (Days 1 to 21)
|
Ortho-Cyclen + Evacetrapib Then Ortho-Cyclen; Sequence BA
Treatment B OC administered orally, QD for 28 days (Days 1 to 28) and 130 mg Evacetrapib orally, QD for 21 days (Days 1 to 21)
Treatment A OC administered orally, QD for 28 days (Days 1 to 28)
|
|---|---|---|---|
|
Lead-In Period
Withdrawal by Subject
|
1
|
0
|
0
|
|
Period 1
Physician Decision
|
0
|
1
|
0
|
|
Period 2
Withdrawal by Subject
|
0
|
0
|
2
|
|
Period 2
Adverse Event
|
0
|
0
|
1
|
|
Period 2
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Evacetrapib in Healthy Female Participants
Baseline characteristics by cohort
| Measure |
Ortho-Cyclen and Ortho-Cyclen + Evacetrapib
n=22 Participants
Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, QD for 28 days (lead-in period).
Treatment A Ortho-Cyclen administered orally, QD for 28 Days (Days 1 to 28) Treatment B Ortho-Cyclen orally, QD for 28 Days (Days 1 to 28) and 130 mg evacetrapib orally, QD for 21 days (Days 1 to 21)
|
|---|---|
|
Age, Continuous
|
33.0 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex/Gender, Customized
Females
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 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
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Ortho-Cyclen
n=16 Participants
Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods.
Ortho-Cyclen: Oral administration
|
Ortho-Cyclen + Evacetrapib
n=17 Participants
Ortho-Cyclen administered orally, once daily (QD) for 28 days (Days 1 to 28) and 130 mg Evacetrapib orally, once daily (QD) for 21 days (Days 1 to 21)
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol
|
71.7 picogram per milliliter (pg/ml)
Geometric Coefficient of Variation 35
|
70.6 picogram per milliliter (pg/ml)
Geometric Coefficient of Variation 37
|
PRIMARY outcome
Timeframe: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Ortho-Cyclen
n=16 Participants
Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods.
Ortho-Cyclen: Oral administration
|
Ortho-Cyclen + Evacetrapib
n=17 Participants
Ortho-Cyclen administered orally, once daily (QD) for 28 days (Days 1 to 28) and 130 mg Evacetrapib orally, once daily (QD) for 21 days (Days 1 to 21)
|
|---|---|---|
|
PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Ethinyl Estradiol
|
907 picogram x hour per ml (pg*hour/ml)
Geometric Coefficient of Variation 31
|
840 picogram x hour per ml (pg*hour/ml)
Geometric Coefficient of Variation 28
|
PRIMARY outcome
Timeframe: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Ortho-Cyclen
n=16 Participants
Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods.
Ortho-Cyclen: Oral administration
|
Ortho-Cyclen + Evacetrapib
n=17 Participants
Ortho-Cyclen administered orally, once daily (QD) for 28 days (Days 1 to 28) and 130 mg Evacetrapib orally, once daily (QD) for 21 days (Days 1 to 21)
|
|---|---|---|
|
PK: Minimum Observed Drug Concentration (Cmin) of Ethinyl Estradiol
|
15.9 pg/ml
Geometric Coefficient of Variation 65
|
13.2 pg/ml
Geometric Coefficient of Variation 66
|
PRIMARY outcome
Timeframe: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Ortho-Cyclen
n=16 Participants
Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods.
Ortho-Cyclen: Oral administration
|
Ortho-Cyclen + Evacetrapib
n=17 Participants
Ortho-Cyclen administered orally, once daily (QD) for 28 days (Days 1 to 28) and 130 mg Evacetrapib orally, once daily (QD) for 21 days (Days 1 to 21)
|
|---|---|---|
|
PK: Time of Maximum Observed Drug Concentration (Tmax) of Ethinyl Estradiol
|
3.00 hour
Interval 0.5 to 12.0
|
4.00 hour
Interval 1.02 to 5.0
|
PRIMARY outcome
Timeframe: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Ortho-Cyclen
n=16 Participants
Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods.
Ortho-Cyclen: Oral administration
|
Ortho-Cyclen + Evacetrapib
n=17 Participants
Ortho-Cyclen administered orally, once daily (QD) for 28 days (Days 1 to 28) and 130 mg Evacetrapib orally, once daily (QD) for 21 days (Days 1 to 21)
|
|---|---|---|
|
PK: Maximum Concentration (Cmax) of Norelgestromin
|
1410 pg/ml
Geometric Coefficient of Variation 21
|
1830 pg/ml
Geometric Coefficient of Variation 17
|
PRIMARY outcome
Timeframe: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Ortho-Cyclen
n=16 Participants
Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods.
Ortho-Cyclen: Oral administration
|
Ortho-Cyclen + Evacetrapib
n=17 Participants
Ortho-Cyclen administered orally, once daily (QD) for 28 days (Days 1 to 28) and 130 mg Evacetrapib orally, once daily (QD) for 21 days (Days 1 to 21)
|
|---|---|---|
|
PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Norelgestromin
|
16200 pg*hour/ml
Geometric Coefficient of Variation 21
|
18100 pg*hour/ml
Geometric Coefficient of Variation 22
|
PRIMARY outcome
Timeframe: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Ortho-Cyclen
n=16 Participants
Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods.
Ortho-Cyclen: Oral administration
|
Ortho-Cyclen + Evacetrapib
n=17 Participants
Ortho-Cyclen administered orally, once daily (QD) for 28 days (Days 1 to 28) and 130 mg Evacetrapib orally, once daily (QD) for 21 days (Days 1 to 21)
|
|---|---|---|
|
PK: Minimum Observed Drug Concentration (Cmin) of Norelgestromin
|
397 pg/ml
Geometric Coefficient of Variation 35
|
422 pg/ml
Geometric Coefficient of Variation 34
|
PRIMARY outcome
Timeframe: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Ortho-Cyclen
n=16 Participants
Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods.
Ortho-Cyclen: Oral administration
|
Ortho-Cyclen + Evacetrapib
n=17 Participants
Ortho-Cyclen administered orally, once daily (QD) for 28 days (Days 1 to 28) and 130 mg Evacetrapib orally, once daily (QD) for 21 days (Days 1 to 21)
|
|---|---|---|
|
PK: Time of Maximum Observed Drug Concentration (Tmax) of Norelgestromin
|
3.53 hour
Interval 2.0 to 12.0
|
4.00 hour
Interval 1.02 to 5.0
|
Adverse Events
Ortho-Cyclen (Lead-in Phase)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Ortho-Cyclen
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Ortho-Cyclen + Evacetrapib
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 |
Ortho-Cyclen (Lead-in Phase)
n=22 participants at risk
Ortho-Cyclen oral doses of (35 mcg ethinyl estradiol and 250 mcg norgestimate) once daily for 28 days (Days 1 to 28)
|
Ortho-Cyclen
n=17 participants at risk
Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily for 28 days (lead-in period). Then, Ortho-Cyclen orally for 28 Days (Days 1 to 28) in one of two treatment periods.
Ortho-Cyclen: Oral administration
|
Ortho-Cyclen + Evacetrapib
n=21 participants at risk
Ortho-Cyclen administered orally for 28 days (lead-in period). Then, Ortho-Cyclen orally for 28 Days (Days 1 to 28) and 130 mg evacetrapib orally for 21 days (Days 1 to 21) in one of two treatment periods.
Ortho-Cyclen: Oral administration
Evacetrapib: Oral administration
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • Number of events 1
|
11.8%
2/17 • Number of events 2
|
4.8%
1/21 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/22
|
5.9%
1/17 • Number of events 1
|
0.00%
0/21
|
|
Nervous system disorders
Dizziness
|
9.1%
2/22 • Number of events 2
|
0.00%
0/17
|
0.00%
0/21
|
|
Nervous system disorders
Headache
|
36.4%
8/22 • Number of events 9
|
5.9%
1/17 • Number of events 1
|
23.8%
5/21 • Number of events 5
|
|
Reproductive system and breast disorders
Menstruation irregular
|
4.5%
1/22 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
0.00%
0/21
|
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