KJ-TFC-004 Drug-drug Interaction Study

NCT02967614 | Completed Phase 1

• 1 other identifier: KJ-TFC-004
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the pharmacokinetic Interaction between Dorzolamide and Brimonidine in healthy male subjects.

Conditions

Glaucoma; Eye Diseases; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of Brimonidine and Dorzolamide

  Group 1 Brimonidine Period 1 : 1d 0h,7d 0h,7d 12h,8d 0h(pre-dose), 8d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 15 Point) Period 2 : 9d 0h,23d 0h,37d 0h,51d 0h,65d 0h,79d 0h,93d 0h,99d 0h,99d 12h, 100d 0h(pre-dose),100d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 21Point) Dorzolamide Period 2 : 9d 0h,23d 0h,37d 0h,51d 0h,65d 0h,79d 0h,93d 0h,99d 0h,99d 12h,100d 0h (pre-dose), 100d 0.25,0.5,0.75,1,1.5,2,2.5,3,4,8,12 h post-dose (Total 21Point) Group 2 Brimonidine Period 2 : 93d 0h,99d 0h,99d 12h,100d 0h(pre-dose),100d 0.25, 0.5, 0.75, 1, 1.5,2,2.5,3,4,8,12h post-dose (Total 15Point) Dorzolamide Period 1 : 1d 0h, 15d 0h, 29d 0h, 43d 0h, 57d 0h, 71d 0h, 85d 0h, 91d 0h, 91d 12h, 92d 0h (pre-dose), 92d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 21Point) Period 2 : 93d 0h, 99d 0h, 99d 12h, 100d 0h (pre-dose), 100d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 15Point)

  pre- and post dose of Brimonidine and Dorzolamide administration]

Secondary Outcomes (1)

• Trough concentration of Dorzolamide and N-Desethyl-Dorzloamide

  pre- and post dose of Dorzolamide and Dorzloamide administration]

Study Arms (2)

[A]→[A]+[B]

EXPERIMENTAL

Period 1 : At each dosing of Treatment A eye drops is administered for 8days Period 2 : At each dosing of Treatment A + Treatment B eye drops is administered for 92days

Drug: [A]; Drug: [A]+[B](1)

[B]→[A]+[B]

EXPERIMENTAL

Period 1 : At each dosing of Treatment B eye drops is administered for 92days Period 2 : At each dosing of Treatment A + Treatment B eye drops is administered for 8days

Drug: [B]; Drug: [A]+[B](2)

Interventions

[A] DRUG

One eye drop(about 40ul) / Day1 \~ Day8 / BID

Also known as: Brimonidine , Timolol

[A]→[A]+[B]

[B] DRUG

One eye drop(about 40ul) / Day1 \~ Day92 / BID

Also known as: Dorzolamide

[B]→[A]+[B]

[A]+[B](1) DRUG

One eye drop(about 40ul) / Day9 \~ Day100 / BID

Also known as: Brimonidine , Timolol , Dorzolamide

[A]→[A]+[B]

[A]+[B](2) DRUG

One eye drop(about 40ul) / Day93 \~ Day100 / BID

Also known as: Brimonidine , Timolol , Dorzolamide

[B]→[A]+[B]

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male adults aged between 19 and 50 during screening period
• BMI more than 18kg / m2 and less than 30kg / m2 and weight more than 55kg
• Signed the informed consent form prior to study participation.

You may not qualify if:

• Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.

Sponsors & Collaborators

• Kukje Pharma: lead

Study Sites (1)

Clinical Trial Center, Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Glaucoma; Eye Diseases; Ocular Hypertension

Interventions

Brimonidine Tartrate, Timolol Maleate Drug Combination; dorzolamide; Brimonidine Tartrate; Timolol

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations; Morpholines; Oxazines

Study Officials

• Kyung-sang Yu, Ph.d., M.B.A

  Clinical Trial Center, Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2016
• First Posted: November 18, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2018
• Last Updated: April 11, 2018

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)