Trial Outcomes & Findings for A Study to Evaluate the Effect of Clarithromycin on LY2216684 (NCT NCT01460407)
NCT ID: NCT01460407
Last Updated: 2018-10-19
Results Overview
AUC0-∞ of LY2216684 was calculated during Period 1, when 18-mg LY2216684 was administered alone and Period 2, when Clarithromycin was coadministered with LY2216684. The outcome was presented as geometric Least Squares (LS) mean and the 90% Confidence Interval (CI). Geometric LS mean was controlled by participant and treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
Predose up to 96 hours post administration of LY2216684 (Day 1) and LY2216684 + Clarithromycin (Day 10)
Results posted on
2018-10-19
Participant Flow
Participant milestones
| Measure |
LY2216684
LY2216684: a single 18-milligram (mg) tablet on Day 1
|
LY2216684 and Clarithromycin
LY2216684: a single 18-mg tablet on Day 10
Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
|---|---|---|
|
Period 1: Day 1 to Day 5
STARTED
|
14
|
0
|
|
Period 1: Day 1 to Day 5
COMPLETED
|
14
|
0
|
|
Period 1: Day 1 to Day 5
NOT COMPLETED
|
0
|
0
|
|
Period 2: Day 6 to Day 14
STARTED
|
0
|
14
|
|
Period 2: Day 6 to Day 14
COMPLETED
|
0
|
13
|
|
Period 2: Day 6 to Day 14
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
LY2216684
LY2216684: a single 18-milligram (mg) tablet on Day 1
|
LY2216684 and Clarithromycin
LY2216684: a single 18-mg tablet on Day 10
Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
|---|---|---|
|
Period 2: Day 6 to Day 14
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Effect of Clarithromycin on LY2216684
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=14 Participants
LY2216684: a single 18-mg tablet on Day 1 and Day 10
Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
|---|---|
|
Age, Continuous
|
43.5 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose up to 96 hours post administration of LY2216684 (Day 1) and LY2216684 + Clarithromycin (Day 10)Population: Full Analysis Set: Participants who received at least 1 dose of LY2216684.
AUC0-∞ of LY2216684 was calculated during Period 1, when 18-mg LY2216684 was administered alone and Period 2, when Clarithromycin was coadministered with LY2216684. The outcome was presented as geometric Least Squares (LS) mean and the 90% Confidence Interval (CI). Geometric LS mean was controlled by participant and treatment.
Outcome measures
| Measure |
LY2216684
n=14 Participants
LY2216684: a single 18-mg tablet on Day 1
|
LY2216684 and Clarithromycin
n=14 Participants
LY2216684: a single 18-mg tablet on Day 10
Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
|---|---|---|
|
Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684
|
582 nanogram*hours per milliliter (ng*h/mL)
Interval 498.0 to 681.0
|
746 nanogram*hours per milliliter (ng*h/mL)
Interval 638.0 to 873.0
|
PRIMARY outcome
Timeframe: Predose up to 96 hours post administration of LY2216684 (Day 1) and LY2216684 + Clarithromycin (Day 10)Population: Full Analysis Set: Participants who received at least 1 dose of LY2216684.
Cmax of LY2216684 was calculated during Period 1, when 18-mg LY2216684 was administered alone, and Period 2, when Clarithromycin was coadministered with LY2216684. The outcome was presented as geometric LS mean and the 90% CI. Geometric LS mean was controlled by participant and treatment.
Outcome measures
| Measure |
LY2216684
n=14 Participants
LY2216684: a single 18-mg tablet on Day 1
|
LY2216684 and Clarithromycin
n=14 Participants
LY2216684: a single 18-mg tablet on Day 10
Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
|---|---|---|
|
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2216684
|
52.58 nanograms per milliliter (ng/mL)
Interval 46.38 to 59.61
|
63.55 nanograms per milliliter (ng/mL)
Interval 56.06 to 72.04
|
PRIMARY outcome
Timeframe: Predose up to 96 hours post administration of LY2216684 (Day 1) and LY2216684 + Clarithromycin (Day 10)Population: Full Analysis Set: Participants who received at least 1 dose of LY2216684.
Tmax of LY2216684 was calculated during Period 1, when 18-mg LY2216684 was administered alone, and Period 2, when Clarithromycin was coadministered with LY2216684. The outcome was presented as geometric LS mean and the 90% CI. Geometric LS mean was controlled by participant and treatment.
Outcome measures
| Measure |
LY2216684
n=14 Participants
LY2216684: a single 18-mg tablet on Day 1
|
LY2216684 and Clarithromycin
n=14 Participants
LY2216684: a single 18-mg tablet on Day 10
Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
|---|---|---|
|
Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684
|
2.00 hours (h)
Interval 1.0 to 5.0
|
2.00 hours (h)
Interval 2.0 to 4.0
|
Adverse Events
LY2216684
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
LY2216684 and Clarithromycin
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Clarithromycin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY2216684
n=14 participants at risk
Adverse Events (AEs) that occurred from Day 1 postdose to Day 6 prior to dosing for all randomized participants.
|
LY2216684 and Clarithromycin
n=14 participants at risk
AEs that occurred from Day 10 postdose to end of study (7 days post last dose) for all randomized participants.
|
Clarithromycin
n=14 participants at risk
AEs that occurred from Day 6 postdose to Day 10 prior to dosing, for all randomized participants.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
7.1%
1/14 • Number of events 1
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
|
Gastrointestinal disorders
Flatulence
|
7.1%
1/14 • Number of events 1
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
7.1%
1/14 • Number of events 1
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
7.1%
1/14 • Number of events 1
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
14.3%
2/14 • Number of events 2
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
|
General disorders
Chest discomfort
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
7.1%
1/14 • Number of events 1
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
7.1%
1/14 • Number of events 1
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 1
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
14.3%
2/14 • Number of events 2
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
7.1%
1/14 • Number of events 1
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 1
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
7.1%
1/14 • Number of events 1
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
7.1%
1/14 • Number of events 1
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14 • Number of events 1
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
7.1%
1/14 • Number of events 1
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
14.3%
2/14 • Number of events 2
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
|
Reproductive system and breast disorders
Penile discharge
|
0.00%
0/8
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
25.0%
2/8 • Number of events 2
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
0.00%
0/8
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
7.1%
1/14 • Number of events 1
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
1/14 • Number of events 1
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
7.1%
1/14 • Number of events 1
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
0.00%
0/14
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
7.1%
1/14 • Number of events 1
All randomized participants were to receive the following treatment regimen: LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10 Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13
|
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