Trial Outcomes & Findings for A Study of LY3050258 in Healthy Participants (NCT NCT01929707)

NCT ID: NCT01929707

Last Updated: 2018-08-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

38 participants

Primary outcome timeframe

Baseline up to 21 days postdose

Results posted on

2018-08-27

Participant Flow

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.

Participant milestones

Participant milestones
Measure	2 mg LY3050258 (Trunk) Period 1: Healthy participants received a topical application of 2 milligrams (mg) LY3050258.	6 mg LY3050258 (Trunk) Period 1: Healthy participants received a topical application of 6 mg LY3050258.	20 mg LY3050258 (Trunk) Period 1: Healthy participants received a topical application of 20 mg LY3050258	Placebo (Trunk) Period 1 or 2: Healthy participants received a topical application of placebo.	60 mg LY3050258 (Trunk) Period 2: Healthy participants received a topical application of 60 mg LY3050258.	200 mg LY3050258 (Trunk) Period 2: Healthy participants received a topical application of 200 mg LY3050258.	20 mg LY3050258 (Axilla) Period 2: Healthy participants received a topical application of 20 mg LY3050258.	Placebo (Axilla) Period 2: Healthy participants received a topical application of placebo.
Intervention Period 1 STARTED	6	8	12	10	0	0	0	0
Intervention Period 1 Received at Least 1 Dose of Study Drug	6	8	12	10	0	0	0	0
Intervention Period 1 COMPLETED	6	8	12	7	0	0	0	0
Intervention Period 1 NOT COMPLETED	0	0	0	3	0	0	0	0
Washout Period ≥7 Days STARTED	6	8	12	7	0	0	0	0
Washout Period ≥7 Days COMPLETED	6	8	12	7	0	0	0	0
Washout Period ≥7 Days NOT COMPLETED	0	0	0	0	0	0	0	0
Intervention Period 2 STARTED	0	0	0	5	6	8	12	4
Intervention Period 2 COMPLETED	0	0	0	5	6	6	12	4
Intervention Period 2 NOT COMPLETED	0	0	0	0	0	2	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo (Trunk) Period 1 or 2: Healthy participants received a topical application of placebo.	200 mg LY3050258 (Trunk) Period 2: Healthy participants received a topical application of 200 mg LY3050258.
Intervention Period 1 Lost to Follow-up	1	0
Intervention Period 1 Withdrawal by Subject	2	0
Intervention Period 2 Withdrawal by Subject	0	2

Baseline Characteristics

A Study of LY3050258 in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LY3050258 or Placebo n=38 Participants 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.
Age, Continuous	49.3 years STANDARD_DEVIATION 11.7 • n=39 Participants
Sex: Female, Male Female	15 Participants n=39 Participants
Sex: Female, Male Male	23 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	9 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	16 Participants n=39 Participants
Race (NIH/OMB) White	13 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Region of Enrollment United States	38 Participants n=39 Participants

PRIMARY outcome

Timeframe: Baseline up to 21 days postdose

Population: All participants who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	2 mg LY3050258 (Trunk) n=6 Participants Period 1: Healthy participants received a topical application of 2 mg LY3050258.	6 mg LY3050258 (Trunk) n=8 Participants Period 1: Healthy participants received a topical application of 6 mg LY3050258.	20 mg LY3050258 (Trunk) n=12 Participants Period 1: Healthy participants received a topical application of 20 mg LY3050258.	Placebo (Trunk) n=15 Participants Period 1 or 2: Healthy participants received a topical application of placebo.	60 mg LY3050258 (Trunk) n=6 Participants Period 2: Healthy participants received a topical application of 60 mg LY3050258.	200 mg LY3050258 (Trunk) n=8 Participants Period 2: Healthy participants received a topical application of 200 mg LY3050258.	20 mg LY3050258 (Axilla) n=12 Participants Period 2: Healthy participants received a topical application of 20 mg LY3050258.	Placebo (Axilla) n=4 Participants Period 2: Healthy participants received a topical application of placebo.
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	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	2 mg LY3050258 (Trunk) n=3 Participants Period 1: Healthy participants received a topical application of 2 mg LY3050258.	6 mg LY3050258 (Trunk) n=8 Participants Period 1: Healthy participants received a topical application of 6 mg LY3050258.	20 mg LY3050258 (Trunk) n=12 Participants Period 1: Healthy participants received a topical application of 20 mg LY3050258.	Placebo (Trunk) n=6 Participants Period 1 or 2: Healthy participants received a topical application of placebo.	60 mg LY3050258 (Trunk) n=8 Participants Period 2: Healthy participants received a topical application of 60 mg LY3050258.	200 mg LY3050258 (Trunk) n=12 Participants Period 2: Healthy participants received a topical application of 200 mg LY3050258.	20 mg LY3050258 (Axilla) Period 2: Healthy participants received a topical application of 20 mg LY3050258.	Placebo (Axilla) Period 2: Healthy participants received a topical application of placebo.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3050258	0.0397 nanograms/milliliter (ng/mL) Geometric Coefficient of Variation 81	0.0626 nanograms/milliliter (ng/mL) Geometric Coefficient of Variation 47	0.968 nanograms/milliliter (ng/mL) Geometric Coefficient of Variation 746	0.681 nanograms/milliliter (ng/mL) Geometric Coefficient of Variation 75	1.77 nanograms/milliliter (ng/mL) Geometric Coefficient of Variation 26	0.630 nanograms/milliliter (ng/mL) Geometric Coefficient of Variation 52	—	—

SECONDARY outcome

Timeframe: 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.