Healthy Volunteers
Conditions
Brief summary
The purpose of this study is to evaluate how safe LY3006072 (study drug) is and whether it causes any side effects. The study will also measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of the study drug. The study drug will be given in the morning or evening with or without a meal. This is the first time that this study drug is being given to humans. This study is for research purposes only and is not intended to treat any medical condition.
Detailed description
This study has two parts: Part A - single ascending dose of LY3006072 administered to healthy participants in 3 of 4 study periods (placebo in 1 of 4 periods). Part B - morning and evening doses of LY3006072 given to healthy participants in fed and fasted states in 2 or 3 of 3 study periods (placebo in 1 of 3 periods for some participants).
Interventions
DRUGPlacebo
Capsules administered orally
DRUGLY3006072
Capsules administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Overtly healthy males or females, as determined by medical history and physical examination * Male participants with a partner of childbearing potential must agree to use barrier protection during sexual intercourse while in the study and for 3 months after the last dose of study drug * Women must not be pregnant or nursing and must be of non-childbearing potential, due to either surgical sterilization or menopause * Body mass index between 19.0 and 30.0 kilograms per square meter (kg/m\^2), inclusive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs | Baseline, up to 21 days | AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible drug relatedness, is located in the Reported Adverse Event module. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3006072 | Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose | — |
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3006072 | Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose | PK: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC\[0-inf\] of LY3006072. |
Countries
United States
Participant flow
Pre-assignment details
This was a 2-part (Part A and Part B) crossover study. Part A was a dose-escalation with up to 3-period crossover with 2 alternating cohorts (Cohorts 1 and 2). There was 14 days of washout time between each dose. Part B was not initiated as study was terminated early due to technical factors.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 (Sequence 1) Participants received LY3006072 and Placebo capsules as per below dosing schedules.
Period 1: 1 milligrams (mg) LY3006072, Period 2: 10 mg LY3006072 and Period 3: Placebo | 3 |
| Cohort 1 (Sequence 2) Participants received LY3006072 and Placebo capsules as per below dosing schedules.
Period 1: 1 mg LY3006072, Period 2: Placebo, Period 3: 40 mg LY3006072 | 2 |
| Cohort 1 (Sequence 3) Participants received LY3006072 and Placebo capsules as per below dosing schedule.
Period 1: Placebo, Period 2: 10 mg LY3006072 and Period 3: 40 mg LY3006072 | 2 |
| Cohort 1 (Sequence 4) Participants received 1 mg, 10 mg and 40 mg of LY3006072 capsules as per below dosing schedule.
Period 1: 1 mg LY3006072, Period 2: 10 mg LY3006072 and Period 3: 40 mg LY3006072 | 2 |
| Cohort 2 (Sequence 1) Participants received Placebo and 20 mg of LY3006072 capsules as per below dosing schedule.
Period 1: Placebo and Period 2: 20 mg LY3006072 | 2 |
| Cohort 2 (Sequence 2) Participants received 3 mg and 20 mg of LY3006072 capsules as per below dosing schedule.
Period 1: 3 mg LY3006072 and Period 2: 20 mg LY3006072 | 5 |
| Cohort 2 (Sequence 3) Participants received Placebo and 3 mg of LY3006072 capsules as per below dosing schedule.
Period 1: 3 mg LY3006072 and Period 2: Placebo | 2 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Period 1 | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Cohort 1 (Sequence 2) | Cohort 1 (Sequence 3) | Cohort 1 (Sequence 4) | Cohort 2 (Sequence 1) | Cohort 1 (Sequence 1) | Cohort 2 (Sequence 2) | Cohort 2 (Sequence 3) |
|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 4 Participants | 2 Participants |
| Region of Enrollment United States | 18 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Female | 12 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 6 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 3 Participants | 0 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 3 / 6 | 1 / 6 | 1 / 6 | 2 / 6 | 6 / 6 |
| serious Total, serious adverse events | 0 / 9 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs
AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible drug relatedness, is located in the Reported Adverse Event module.
Time frame: Baseline, up to 21 days
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs | Serious AEs | 0 Participants |
| Placebo | Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs | Other Non-Serious AEs | 0 Participants |
| 1 mg LY3006072 | Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs | Serious AEs | 0 Participants |
| 1 mg LY3006072 | Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs | Other Non-Serious AEs | 3 Participants |
| 3 mg LY3006072 | Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs | Serious AEs | 0 Participants |
| 3 mg LY3006072 | Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs | Other Non-Serious AEs | 1 Participants |
| 10 mg LY3006072 | Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs | Serious AEs | 0 Participants |
| 10 mg LY3006072 | Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs | Other Non-Serious AEs | 1 Participants |
| 20 mg LY3006072 | Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs | Serious AEs | 0 Participants |
| 20 mg LY3006072 | Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs | Other Non-Serious AEs | 2 Participants |
| 40 mg LY3006072 | Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs | Serious AEs | 0 Participants |
| 40 mg LY3006072 | Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs | Other Non-Serious AEs | 6 Participants |
Secondary
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3006072
PK: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC\[0-inf\] of LY3006072.
Time frame: Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose
Population: All randomized participants who received at least one dose of study drug and have evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3006072 | 1530 nanograms * hours per mL (ng*hr/mL) | Geometric Coefficient of Variation 47 |
| 1 mg LY3006072 | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3006072 | 4800 nanograms * hours per mL (ng*hr/mL) | Geometric Coefficient of Variation 34 |
| 3 mg LY3006072 | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3006072 | 14400 nanograms * hours per mL (ng*hr/mL) | Geometric Coefficient of Variation 25 |
| 10 mg LY3006072 | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3006072 | 24700 nanograms * hours per mL (ng*hr/mL) | Geometric Coefficient of Variation 27 |
| 20 mg LY3006072 | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3006072 | 65600 nanograms * hours per mL (ng*hr/mL) | Geometric Coefficient of Variation 21 |
Secondary
Pharmacokinetics: Maximum Concentration (Cmax) of LY3006072
Time frame: Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose
Population: All randomized participants who received at least one dose of study drug and have evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pharmacokinetics: Maximum Concentration (Cmax) of LY3006072 | 18.8 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 20 |
| 1 mg LY3006072 | Pharmacokinetics: Maximum Concentration (Cmax) of LY3006072 | 57.0 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 12 |
| 3 mg LY3006072 | Pharmacokinetics: Maximum Concentration (Cmax) of LY3006072 | 160 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 24 |
| 10 mg LY3006072 | Pharmacokinetics: Maximum Concentration (Cmax) of LY3006072 | 263 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 42 |
| 20 mg LY3006072 | Pharmacokinetics: Maximum Concentration (Cmax) of LY3006072 | 576 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 31 |