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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02134834




Registration number
NCT02134834
Ethics application status
Date submitted
7/05/2014
Date registered
9/05/2014
Date last updated
12/12/2014

Titles & IDs
Public title
A Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of OP0595
Scientific title
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of OP0595 Administered Intravenously in Healthy Male Subjects.
Secondary ID [1] 0 0
OP0595-1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Bacterial Infections 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - OP0595
Treatment: Drugs - Placebo

Experimental: Ascending single dose of OP0595 -

Placebo comparator: Normal Saline -


Treatment: Drugs: OP0595
Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation

Treatment: Drugs: Placebo
Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety from baseline through the end of the study
Timepoint [1] 0 0
Day 1 to Day 7
Secondary outcome [1] 0 0
Plasma PK parameters of OP0595 and its metabolites
Timepoint [1] 0 0
Day 1 to Day 2
Secondary outcome [2] 0 0
Urine PK parameters of OP0595 and its metabolites
Timepoint [2] 0 0
Day 1 to Day 2

Eligibility
Key inclusion criteria
* Caucasian males aged between 18 and 45 years (inclusive) at Screening
* A Body Mass Index (BMI) between 18.0 and 30.0 kg/m² (inclusive) at Screening
* Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests
* Negative urine test for drugs of abuse and breath test for alcohol both at Screening and Day -1
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Receipt of any investigational agent or drug within four months before Screening
* A history or current evidence of allergic symptoms such as bronchial asthma, drug-induced rash or urticaria
* Hypersensitivity and/or allergy to drugs
* Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders
* A history of chronic or recurrent infections or current active infection
* A recent history of surgery within three months prior to Screening, determined by the Investigator to be clinically relevant
* A history or presence of malignancy
* Donation of blood (or loss of blood) greater than 400 ml within three months before Screening
* A history of smoking at any time within one year before Screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
- Perth,
Recruitment postcode(s) [1] 0 0
- Perth,

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Meiji Seika Pharma Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mitsuharu Egawa
Address 0 0
Meiji Seika Pharma Co., Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02134834