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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02108288
Enrollment
30
Registered
2014-04-09
Start date
2014-04-30
Completion date
2014-08-31
Last updated
2015-04-22

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

Conditions

Glaucoma, Ocular Hypertension

Brief summary

OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost ophthalmic solution are administered once daily for 7 days and the effect on the blood concentration of carteolol and latanoprost in OPC-1085EL ophthalmic solution by formulating the combination drug will be determined.

Interventions

DRUGOPC-1085EL ophthalmic solution
DRUGCarteolol long-acting ophthalmic solution
DRUGLatanoprost ophthalmic solution

Sponsors

Otsuka Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Subjects who are considered medically healthy per investigator's judgment

Exclusion criteria

* Subjects with ocular conditions as defined by the protocol * Subjects with intraocular pressure: \<10 or ≥22 mmHg

Design outcomes

Primary

MeasureTime frame
Cmax of CarteololDay 1 and Day 7
Cmax of Latanoprost AcidDay 1 and Day 7

Secondary

MeasureTime frame
Tmax of CarteololDay 1 and Day 7
Tmax of Latanoprost AcidDay 1 and Day 7

Countries

Japan

Participant flow

Participants by arm

ArmCount
OPC-1085EL Ophthalmic Solution
Once daily OPC-1085EL ophthalmic solution
10
Carteolol Long-acting Ophthalmic Solution
Once daily Carteolol long-acting ophthalmic solution
10
Latanoprost Ophthalmic Solution
Once daily Latanoprost ophthalmic solution
10
Total30

Baseline characteristics

CharacteristicCarteolol Long-acting Ophthalmic SolutionLatanoprost Ophthalmic SolutionOPC-1085EL Ophthalmic SolutionTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
10 Participants10 Participants10 Participants30 Participants
Age, Continuous25.5 years
STANDARD_DEVIATION 3
24.0 years
STANDARD_DEVIATION 2.8
26.7 years
STANDARD_DEVIATION 5.7
25.4 years
STANDARD_DEVIATION 4.1
Region of Enrollment
Japan
10 participants10 participants10 participants30 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Male
10 Participants10 Participants10 Participants30 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
6 / 104 / 108 / 10
serious
Total, serious adverse events
0 / 100 / 100 / 10

Outcome results

Primary

Cmax of Carteolol

Time frame: Day 1 and Day 7

ArmMeasureGroupValue (MEAN)Dispersion
OPC-1085EL Ophthalmic SolutionCmax of CarteololDay 10.8558 ng/mLStandard Deviation 0.2658
OPC-1085EL Ophthalmic SolutionCmax of CarteololDay 71.174 ng/mLStandard Deviation 0.3085
Carteolol Long-acting Ophthalmic SolutionCmax of CarteololDay 10.9984 ng/mLStandard Deviation 0.4832
Carteolol Long-acting Ophthalmic SolutionCmax of CarteololDay 71.627 ng/mLStandard Deviation 0.5001
Primary

Cmax of Latanoprost Acid

Time frame: Day 1 and Day 7

ArmMeasureGroupValue (MEAN)Dispersion
OPC-1085EL Ophthalmic SolutionCmax of Latanoprost AcidDay 119.77 pg/mLStandard Deviation 10.13
OPC-1085EL Ophthalmic SolutionCmax of Latanoprost AcidDay 718.47 pg/mLStandard Deviation 8.913
Carteolol Long-acting Ophthalmic SolutionCmax of Latanoprost AcidDay 121.22 pg/mLStandard Deviation 10.16
Carteolol Long-acting Ophthalmic SolutionCmax of Latanoprost AcidDay 717.48 pg/mLStandard Deviation 8.892
Secondary

Tmax of Carteolol

Time frame: Day 1 and Day 7

ArmMeasureGroupValue (MEDIAN)
OPC-1085EL Ophthalmic SolutionTmax of CarteololDay 10.25 h
OPC-1085EL Ophthalmic SolutionTmax of CarteololDay 70.25 h
Carteolol Long-acting Ophthalmic SolutionTmax of CarteololDay 10.25 h
Carteolol Long-acting Ophthalmic SolutionTmax of CarteololDay 70.38 h
Secondary

Tmax of Latanoprost Acid

Time frame: Day 1 and Day 7

ArmMeasureGroupValue (MEDIAN)
OPC-1085EL Ophthalmic SolutionTmax of Latanoprost AcidDay 110 min
OPC-1085EL Ophthalmic SolutionTmax of Latanoprost AcidDay 75 min
Carteolol Long-acting Ophthalmic SolutionTmax of Latanoprost AcidDay 110 min
Carteolol Long-acting Ophthalmic SolutionTmax of Latanoprost AcidDay 710 min

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