FindTrial
Sign In

Study of LY3039478 in Healthy Participants

An Absolute Bioavailability Study of LY3039478 in Healthy Subjects Using the Intravenous Tracer Method

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02906618
Enrollment
12
Registered
2016-09-20
Start date
2016-10-04
Completion date
2016-11-11
Last updated
2025-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

The study involves one dose of LY3039478 given by mouth followed by an intravenous infusion (IV) (via a tube linked to a small needle in the vein) of LY3039478. The results of this study will help to answer the following research questions: * How much LY3039478 gets into the blood stream when given by mouth as a capsule compared to when given by an IV * How long it takes the body to remove the study drug * The safety of LY3039478 and any side effects that might be associated with it Participation in the study is expected to last up to 7 weeks. There will be screening, a single study period, and a follow-up.

Interventions

DRUGLY3039478

Administered orally

DRUG13C 15N 2H-LY3039478 IV

Administered IV

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

\- Have a body mass index (BMI) of 18.5 to 32.0 kilogram per meter square (kg/m²) inclusive

Exclusion criteria

\- Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product • Have known allergies to LY3039478, related compounds or any components of the formulation, or history of significant atopy in the opinion of the investigator

Design outcomes

Primary

MeasureTime frameDescription
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3039478 and 13C 15N 2H-LY3039478Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours PostdosePharmacokinetics (PK) is the area under the concentration versus time curve (AUC) from time zero to the last time point with a measurable concentration (AUC\[0-tlast\]) of LY3039478 and 13C 15N 2H-LY3039478.
PK: AUC From Zero to Infinity (AUC[0 - Inf]) of LY3039478 and 13C 15N 2H-LY3039478Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours PostdosePK is AUC from zero to infinity (AUC\[0 - inf\]) of LY3039478 and 13C 15N 2H-LY3039478.

Secondary

MeasureTime frameDescription
PK: Maximum Observed Drug Concentration (Cmax) of LY3039478 and 13C 15N 2H-LY3039478 - IVPredose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours PostdosePK is the maximum observed drug concentration (cmax) of LY3039478 13C 15N 2H-LY3039478 - IV.
PK: Time of Cmax (Tmax) of LY3039478 and 13C 15N 2H-LY3039478Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours PostdosePK is the time of Cmax (tmax) of LY3039478 and 13C 15N 2H-LY3039478.
PK: Half Life Associated With The Terminal Rate Constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours PostdosePK is the half life associated with the terminal rate constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478.

Countries

United Kingdom

Participant flow

Participants by arm

ArmCount
Overall
LY3039478 given once, orally and 13C 15N 2H-LY3039478 given once, IV.
12
Total12

Baseline characteristics

CharacteristicOverall
Age, Continuous40.9 years
STANDARD_DEVIATION 15
Body Mass Index (BMI)25.82 kilogram/square meter (kg/m²)
STANDARD_DEVIATION 2.5
Body Weight80.97 kilogram (kg)
STANDARD_DEVIATION 10
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Height177.00 centimeter (cm)
STANDARD_DEVIATION 7.41
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 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
12 Participants
Region of Enrollment
United Kingdom
12 Participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
12 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
2 / 12
serious
Total, serious adverse events
0 / 12

Outcome results

Primary

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3039478 and 13C 15N 2H-LY3039478

Pharmacokinetics (PK) is the area under the concentration versus time curve (AUC) from time zero to the last time point with a measurable concentration (AUC\[0-tlast\]) of LY3039478 and 13C 15N 2H-LY3039478.

Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose

Population: All participants who received at least one dose of study drug.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
LY3039478 - OralPharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3039478 and 13C 15N 2H-LY30394781920 nangogram*hour/milliliter (ng*h/mL)Geometric Coefficient of Variation 23
13C 15N 2H-LY3039478 - IVPharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3039478 and 13C 15N 2H-LY303947815.6 nangogram*hour/milliliter (ng*h/mL)Geometric Coefficient of Variation 16
Primary

PK: AUC From Zero to Infinity (AUC[0 - Inf]) of LY3039478 and 13C 15N 2H-LY3039478

PK is AUC from zero to infinity (AUC\[0 - inf\]) of LY3039478 and 13C 15N 2H-LY3039478.

Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose

Population: All participants who received at least one dose of study drug.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
LY3039478 - OralPK: AUC From Zero to Infinity (AUC[0 - Inf]) of LY3039478 and 13C 15N 2H-LY30394781920 ng*hr/mLGeometric Coefficient of Variation 23
13C 15N 2H-LY3039478 - IVPK: AUC From Zero to Infinity (AUC[0 - Inf]) of LY3039478 and 13C 15N 2H-LY303947815.6 ng*hr/mLGeometric Coefficient of Variation 16
90% CI: [0.532, 0.615]
Secondary

PK: Half Life Associated With The Terminal Rate Constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478

PK is the half life associated with the terminal rate constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478.

Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose

Population: All participants who received at least one dose of study drug.

ArmMeasureValue (GEOMETRIC_MEAN)
LY3039478 - OralPK: Half Life Associated With The Terminal Rate Constant (t1/2) of LY3039478 and 13C 15N 2H-LY30394785.42 hr
13C 15N 2H-LY3039478 - IVPK: Half Life Associated With The Terminal Rate Constant (t1/2) of LY3039478 and 13C 15N 2H-LY30394783.31 hr
Secondary

PK: Maximum Observed Drug Concentration (Cmax) of LY3039478 and 13C 15N 2H-LY3039478 - IV

PK is the maximum observed drug concentration (cmax) of LY3039478 13C 15N 2H-LY3039478 - IV.

Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose

Population: All participants who received at least one dose of study drug.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
LY3039478 - OralPK: Maximum Observed Drug Concentration (Cmax) of LY3039478 and 13C 15N 2H-LY3039478 - IV444 nanogram/millilter (ng/mL)Geometric Coefficient of Variation 23
13C 15N 2H-LY3039478 - IVPK: Maximum Observed Drug Concentration (Cmax) of LY3039478 and 13C 15N 2H-LY3039478 - IV7.24 nanogram/millilter (ng/mL)Geometric Coefficient of Variation 15
Secondary

PK: Time of Cmax (Tmax) of LY3039478 and 13C 15N 2H-LY3039478

PK is the time of Cmax (tmax) of LY3039478 and 13C 15N 2H-LY3039478.

Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose

Population: All participants who received at least one dose of study drug.

ArmMeasureValue (MEDIAN)
LY3039478 - OralPK: Time of Cmax (Tmax) of LY3039478 and 13C 15N 2H-LY30394781.500 hour (hr)
13C 15N 2H-LY3039478 - IVPK: Time of Cmax (Tmax) of LY3039478 and 13C 15N 2H-LY30394780.750 hour (hr)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026