Trial Outcomes & Findings for Pharmacokinetic Study of OPC-1085EL Ophthalmic Solution in Healthy Male Adult Volunteers (NCT NCT02108288)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

30 participants

Primary outcome timeframe

Day 1 and Day 7

Results posted on

2015-04-22

Participant Flow

Participant milestones

Participant milestones
Measure	OPC-1085EL Ophthalmic Solution Once daily OPC-1085EL ophthalmic solution	Carteolol Long-acting Ophthalmic Solution Once daily Carteolol long-acting ophthalmic solution	Latanoprost Ophthalmic Solution Once daily Latanoprost ophthalmic solution
Overall Study STARTED	10	10	10
Overall Study COMPLETED	10	10	10
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetic Study of OPC-1085EL Ophthalmic Solution in Healthy Male Adult Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OPC-1085EL Ophthalmic Solution n=10 Participants Once daily OPC-1085EL ophthalmic solution	Carteolol Long-acting Ophthalmic Solution n=10 Participants Once daily Carteolol long-acting ophthalmic solution	Latanoprost Ophthalmic Solution n=10 Participants Once daily Latanoprost ophthalmic solution	Total n=30 Participants Total of all reporting groups
Sex: Female, Male Male	10 Participants n=99 Participants	10 Participants n=107 Participants	10 Participants n=206 Participants	30 Participants n=7 Participants
Region of Enrollment Japan	10 participants n=99 Participants	10 participants n=107 Participants	10 participants n=206 Participants	30 participants n=7 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=99 Participants	10 Participants n=107 Participants	10 Participants n=206 Participants	30 Participants n=7 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Continuous	26.7 years STANDARD_DEVIATION 5.7 • n=99 Participants	25.5 years STANDARD_DEVIATION 3.0 • n=107 Participants	24.0 years STANDARD_DEVIATION 2.8 • n=206 Participants	25.4 years STANDARD_DEVIATION 4.1 • n=7 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants

PRIMARY outcome

Timeframe: Day 1 and Day 7

Outcome measures

Outcome measures
Measure	OPC-1085EL Ophthalmic Solution n=10 Participants Once daily OPC-1085EL ophthalmic solution	Carteolol Long-acting Ophthalmic Solution n=10 Participants Once daily Carteolol long-acting ophthalmic solution
Cmax of Carteolol Day 1	0.8558 ng/mL Standard Deviation 0.2658	0.9984 ng/mL Standard Deviation 0.4832
Cmax of Carteolol Day 7	1.174 ng/mL Standard Deviation 0.3085	1.627 ng/mL Standard Deviation 0.5001

PRIMARY outcome

Timeframe: Day 1 and Day 7

Outcome measures

Outcome measures
Measure	OPC-1085EL Ophthalmic Solution n=10 Participants Once daily OPC-1085EL ophthalmic solution	Carteolol Long-acting Ophthalmic Solution n=10 Participants Once daily Carteolol long-acting ophthalmic solution
Cmax of Latanoprost Acid Day 1	19.77 pg/mL Standard Deviation 10.13	21.22 pg/mL Standard Deviation 10.16
Cmax of Latanoprost Acid Day 7	18.47 pg/mL Standard Deviation 8.913	17.48 pg/mL Standard Deviation 8.892

SECONDARY outcome

Timeframe: Day 1 and Day 7

Outcome measures

Outcome measures
Measure	OPC-1085EL Ophthalmic Solution n=10 Participants Once daily OPC-1085EL ophthalmic solution	Carteolol Long-acting Ophthalmic Solution n=10 Participants Once daily Carteolol long-acting ophthalmic solution
Tmax of Carteolol Day 1	0.25 h Interval 0.25 to 4.0	0.25 h Interval 0.25 to 23.92
Tmax of Carteolol Day 7	0.25 h Interval 0.25 to 4.0	0.38 h Interval 0.25 to 24.0

SECONDARY outcome

Timeframe: Day 1 and Day 7

Outcome measures

Outcome measures
Measure	OPC-1085EL Ophthalmic Solution n=10 Participants Once daily OPC-1085EL ophthalmic solution	Carteolol Long-acting Ophthalmic Solution n=10 Participants Once daily Carteolol long-acting ophthalmic solution
Tmax of Latanoprost Acid Day 1	10 min Interval 5.0 to 10.0	10 min Interval 5.0 to 10.0
Tmax of Latanoprost Acid Day 7	5 min Interval 5.0 to 10.0	10 min Interval 5.0 to 10.0

Adverse Events

OPC-1085EL Ophthalmic Solution

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Carteolol Long-acting Ophthalmic Solution

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Latanoprost Ophthalmic Solution

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	OPC-1085EL Ophthalmic Solution n=10 participants at risk Once daily OPC-1085EL ophthalmic solution	Carteolol Long-acting Ophthalmic Solution n=10 participants at risk Once daily Carteolol long-acting ophthalmic solution	Latanoprost Ophthalmic Solution n=10 participants at risk Once daily Latanoprost ophthalmic solution
Eye disorders Accommodation disorder	0.00% 0/10 • Up to 24 days from date of informed consent	10.0% 1/10 • Number of events 1 • Up to 24 days from date of informed consent	0.00% 0/10 • Up to 24 days from date of informed consent
Eye disorders Conjunctival hyperaemia	60.0% 6/10 • Number of events 10 • Up to 24 days from date of informed consent	30.0% 3/10 • Number of events 3 • Up to 24 days from date of informed consent	80.0% 8/10 • Number of events 11 • Up to 24 days from date of informed consent
Eye disorders Eye pruritus	0.00% 0/10 • Up to 24 days from date of informed consent	0.00% 0/10 • Up to 24 days from date of informed consent	10.0% 1/10 • Number of events 1 • Up to 24 days from date of informed consent
Eye disorders Corneal disorder	0.00% 0/10 • Up to 24 days from date of informed consent	0.00% 0/10 • Up to 24 days from date of informed consent	30.0% 3/10 • Number of events 3 • Up to 24 days from date of informed consent

Additional Information

Director of Clinical Research and Development

Otsuka Pharmaceutical Co., Ltd

Phone: +81-3-6361-7366

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place