Healthy Participants
Conditions
Brief summary
The main purpose of this study is to evaluate the safety and how well the body will handle a single dose of increasing strength of study drug LY3050258. Each participant will receive LY3050258 or placebo once, in each of 2 dosing periods. At least 7 days will pass between doses. This study will last approximately 45 days for each participant. Screening is required within 28 days before the start of the study.
Interventions
DRUGLY3050258
DRUGPlacebo
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males or healthy postmenopausal females, including Japanese participants * Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m\^2)
Exclusion criteria
* An abnormal sitting blood pressure as determined by the investigator * Any abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, places the participant at an unacceptable risk for study participation * Current use of statins within the last 3 months prior to dosing * Current or previous use of anabolic steroids in the preceding 6 months prior to dosing * Use of dehydroepiandrosterone, other potential over-the-counter (OTC) steroidal supplements, or other nutritional products intended to have weight-reduction and/or performance-enhancing effects within 21 days prior to dosing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline up to 21 days postdose | Data presented are the number of participants who experienced SAEs which were considered to be related to study treatment by the investigator while on treatment and during the follow-up. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module. |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3050258 | Period 1: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours (h) postdose and Day 7 postdose; Period 2: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Days 7, 14, and 21 postdose. |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3050258 | Period 1: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Day 7 postdose; Period 2: predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Days 7, 14, and 21 postdose |
Countries
United States
Participant flow
Pre-assignment details
This was a single-dose, incomplete-crossover, dose-escalation study with minimum 7 days between dosing periods. Each participant received either 2 topical doses of LY3050258 or 1 topical dose each of LY3050258 and placebo. Two discontinued participants completing Period 1 were replaced in Period 2.
Participants by arm
| Arm | Count |
|---|---|
| LY3050258 or Placebo Participants received doses of 2, 6, or 20 mg LY3050258 or placebo during Period 1 by topical administration on the trunk. Participants received 60, 200 mg LY3050258 or placebo on the trunk or 20 mg LY3050258 or placebo by topical administration on the axilla during Period 2. There were at least 7 days between treatments. | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Intervention Period 1 | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Intervention Period 1 | Withdrawal by Subject | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Intervention Period 2 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | LY3050258 or Placebo |
|---|---|
| Age, Continuous | 49.3 years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 38 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 8 | 1 / 12 | 1 / 12 | 0 / 6 | 1 / 8 | 1 / 15 | 1 / 4 |
| serious Total, serious adverse events | 0 / 6 | 0 / 8 | 0 / 12 | 0 / 12 | 0 / 6 | 0 / 8 | 0 / 15 | 0 / 4 |
Outcome results
Primary
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Data presented are the number of participants who experienced SAEs which were considered to be related to study treatment by the investigator while on treatment and during the follow-up. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module.
Time frame: Baseline up to 21 days postdose
Population: All participants who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2 mg LY3050258 (Trunk) | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 6 mg LY3050258 (Trunk) | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 20 mg LY3050258 (Trunk) | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| Placebo (Trunk) | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 60 mg LY3050258 (Trunk) | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 200 mg LY3050258 (Trunk) | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 20 mg LY3050258 (Axilla) | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| Placebo (Axilla) | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
Secondary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3050258
Time frame: Period 1: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours (h) postdose and Day 7 postdose; Period 2: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Days 7, 14, and 21 postdose.
Population: All randomized participants who received at least 1 dose of study drug and had evaluable PK data to calculate Cmax. Participants were analyzed based on the treatment they received.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 2 mg LY3050258 (Trunk) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3050258 | 0.0397 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 81 |
| 6 mg LY3050258 (Trunk) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3050258 | 0.0626 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 47 |
| 20 mg LY3050258 (Trunk) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3050258 | 0.968 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 746 |
| Placebo (Trunk) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3050258 | 0.681 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 75 |
| 60 mg LY3050258 (Trunk) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3050258 | 1.77 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 26 |
| 200 mg LY3050258 (Trunk) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3050258 | 0.630 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 52 |
Secondary
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3050258
Time frame: Period 1: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Day 7 postdose; Period 2: predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Days 7, 14, and 21 postdose
Population: All randomized participants who received at least 1 dose of study drug and had evaluable PK data to calculate AUC(0-∞). Participants were analyzed based on the treatment they received.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 2 mg LY3050258 (Trunk) | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3050258 | 1.60 nanograms*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 95 |
| 6 mg LY3050258 (Trunk) | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3050258 | 7.02 nanograms*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 161 |
| 20 mg LY3050258 (Trunk) | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3050258 | 17.5 nanograms*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 198 |
| Placebo (Trunk) | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3050258 | 41.6 nanograms*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 81 |
| 60 mg LY3050258 (Trunk) | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3050258 | 88.5 nanograms*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 35 |
| 200 mg LY3050258 (Trunk) | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3050258 | 23.0 nanograms*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 37 |