Trial Outcomes & Findings for Study of LC23-1306 in Healthy Male Subjects (NCT NCT01526577)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

113 participants

Primary outcome timeframe

7 days (plus or minus 1 day)

Results posted on

2018-08-13

Participant Flow

* Recruitment location: Seoul University Hospital * Recruitment period: * Single dose study recruitment period: 12Mar2012 \~ 18Sep2012 * Muti-dose study recruitment period: 02Dec2012 \~ 05Aug2013

The subjects were enrolled in single dose study and multiple study separately. The subject enrolled in single dose study was not allowed to be enrolled in multiple dose study.

Participant milestones

Participant milestones
Measure	Single Dosing LC23-1306 experimental drug LC23-1306 10, 30, 100, 200, 400, 600 mg	Single Dosing Placebo	Multiple Dosing LC23-1306 LC23-1306 100, 200, 400, 600mg	Multiple Dosing Placebo	Multiple Dosing Ticagrelor 90mg Active comparator
Overall Study STARTED	49	12	33	9	10
Overall Study COMPLETED	48	12	32	8	8
Overall Study NOT COMPLETED	1	0	1	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of LC23-1306 in Healthy Male Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Dosing LC23-1306 n=49 Participants Experimental drug LC23-1306 10, 30, 100, 200, 400, 600 mg	Single Dosing Placebo n=12 Participants	Multiple Dosing LC23-1306 n=33 Participants Experimental drug LC23-1306 100, 200, 400, 600mg	Multiple Dosing Placebo n=9 Participants	Multiple Dosing Ticagrelor 90mg n=10 Participants Active comparator	Total n=113 Participants Total of all reporting groups
Age, Continuous Age	27 years STANDARD_DEVIATION 4 • n=5 Participants	27 years STANDARD_DEVIATION 3 • n=7 Participants	28 years STANDARD_DEVIATION 4 • n=5 Participants	26 years STANDARD_DEVIATION 4 • n=4 Participants	31 years STANDARD_DEVIATION 6 • n=21 Participants	27 years STANDARD_DEVIATION 4 • n=8 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	12 Participants n=7 Participants	33 Participants n=5 Participants	9 Participants n=4 Participants	10 Participants n=21 Participants	113 Participants n=8 Participants

PRIMARY outcome

Timeframe: 7 days (plus or minus 1 day)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1D 0, 2, 8, 24h for single dose study / 1D and 7D 0, 2, 8, 12, 24h for multiple dose study

Inhibition of platelet aggregation (IPA) was analized by the platelet aggregation test. \* Among the time points that platelet aggregation rate was meausred, the result only at 8h post dosing was provided in result section.

Outcome measures

Outcome measures
Measure	LC23-1306 n=80 Participants experimental drug LC23-1306: LC23-1306 10, 30, 100, 200, 400, 600 mg Placebo 10, 30, 100, 200, 400, 600 mg	Placebo n=20 Participants LC23-1306 placebo placebo: LC23-1306 placebo	Ticagrelor n=8 Participants active comparator Ticagrelor: Ticagrelor 90mg
Pharmacodynamic Measurement	70 percentage of platelet inhibition	30 percentage of platelet inhibition	91.9 percentage of platelet inhibition

PRIMARY outcome

Timeframe: pre-dose, up to 1 day post-dose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre-dose, up to 3 days post-dose

Outcome measures

Outcome data not reported

Adverse Events

LC23-1306

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

Ticagrelar

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	LC23-1306 n=82 participants at risk Test drug.	Ticagrelar n=10 participants at risk Active comparator	Placebo n=21 participants at risk
Gastrointestinal disorders Nausea and so on.	52.4% 43/82 • Number of events 50	100.0% 10/10 • Number of events 13	38.1% 8/21 • Number of events 8

Additional Information

Dong Yeop Shin

LG Life Sciences

Phone: 82 2 6924 3114

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place