Healthy
Conditions
Brief summary
The purpose of this study is to compare two different formulations of ixekizumab. One formulation (Reference) is approved by the Food and Drug Administration (FDA) and one formulation (Test) is not approved. This study will compare how much of each formulation gets into the blood stream. Information about any side effects that may occur will also be collected. The study will last up to about four months for each participant.
Interventions
DRUGIxekizumab
Administered SC.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Are healthy male or female participants, with chronic stable medical problems, that in the investigator's opinion will not place the subject at increased risk by participating in the study
Exclusion criteria
* Have a significant history of, or current, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or hematologic disorders that in the opinion of the investigator poses an unacceptable risk to the participant if participating in the study * Are allergic or hypersensitive to the study medicine * Had a vaccination with a live vaccine within 12 months prior to the first check-in or intend to get a vaccine for tuberculosis within 12 months of completing treatment on this study * Have any type of hepatitis, human immunodeficiency virus (HIV) infection, or other serious infection * Show evidence of active or latent tuberculosis (TB) * Presence of significant neuropsychiatric disorder or a recent history of depression * Have had any active or recent infection within 4 weeks of Day 1 that, in the opinion of the investigator, would pose an unacceptable risk to the participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab | Predose, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 Post Dose | PK: Cmax of ixekizumab was evaluated |
| PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab | Predose, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 Post Dose | Area under the plasma concentration versus time curve from time zero to the last measured concentration value (AUC\[0-tlast\]). AUC 0-tlast is equal to AUC (0-85) days where the last time point was 85 Days ± 3 Days. |
| PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab | Predose, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 Post Dose | Area under the plasma concentration versus time curve from zero to infinity (AUC\[0-∞\]) of a single dose of Ixekizumab. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 80 mg Ixekizumab (Reference) Participants received 80 mg ixekizumab of approved commercial formulation (Reference) administered as a SC injection via AI. | 126 |
| 80 mg Ixekizumab (Test) Participants received 80 mg ixekizumab alternate formulation (Test) administered as a SC injection via AI. | 119 |
| Total | 245 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | 80 mg Ixekizumab (Reference) | Total | 80 mg Ixekizumab (Test) |
|---|---|---|---|
| Age, Continuous | 42.9 years STANDARD_DEVIATION 12.8 | 44.8 years STANDARD_DEVIATION 13.2 | 46.8 years STANDARD_DEVIATION 13.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 58 Participants | 104 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 68 Participants | 141 Participants | 73 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants | 51 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 93 Participants | 191 Participants | 98 Participants |
| Region of Enrollment United States | 126 Participants | 245 Participants | 119 Participants |
| Sex: Female, Male Female | 67 Participants | 127 Participants | 60 Participants |
| Sex: Female, Male Male | 59 Participants | 118 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 126 | 0 / 119 |
| other Total, other adverse events | 36 / 126 | 14 / 119 |
| serious Total, serious adverse events | 0 / 126 | 0 / 119 |
Outcome results
Primary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab
PK: Cmax of ixekizumab was evaluated
Time frame: Predose, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 Post Dose
Population: Only participants who had all PK samples collected up to Day 85 or participants who had one missing PK sample after Day 15 but with at least 3 data points and R squared adjusted (Rsq adj) greater than (\>) 0.7 to calculate half-life parameter included in the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 80 mg Ixekizumab (Reference) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab | 9.66 micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 33 |
| 80 mg Ixekizumab (Test) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab | 9.97 micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 35 |
Primary
PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab
Area under the plasma concentration versus time curve from time zero to the last measured concentration value (AUC\[0-tlast\]). AUC 0-tlast is equal to AUC (0-85) days where the last time point was 85 Days ± 3 Days.
Time frame: Predose, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 Post Dose
Population: Only participants who had all PK samples collected up to Day 85 or participants who had one missing PK sample after Day 15 but with at least 3 data points and Rsq adj\>0.7 to calculate half-life parameter included in the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 80 mg Ixekizumab (Reference) | PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab | 207 microgram*day/milliliter (ug*day/mL) | Geometric Coefficient of Variation 31 |
| 80 mg Ixekizumab (Test) | PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab | 219 microgram*day/milliliter (ug*day/mL) | Geometric Coefficient of Variation 28 |
Primary
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab
Area under the plasma concentration versus time curve from zero to infinity (AUC\[0-∞\]) of a single dose of Ixekizumab.
Time frame: Predose, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 Post Dose
Population: Only participants who had all PK samples collected up to Day 85 or participants who had one missing PK sample after Day 15 but with at least 3 data points and Rsq adj\>0.7 to calculate half-life parameter included in the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 80 mg Ixekizumab (Reference) | PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab | 213 ug*day/mL | Geometric Coefficient of Variation 33 |
| 80 mg Ixekizumab (Test) | PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab | 227 ug*day/mL | Geometric Coefficient of Variation 30 |