Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02357524




Registration number
NCT02357524
Ethics application status
Date submitted
27/01/2015
Date registered
6/02/2015
Date last updated
19/12/2023

Titles & IDs
Public title
Oritavancin on the Results of Multiple Coagulation Tests in Healthy Volunteers
Scientific title
A Single Center, Open-label Study to Evaluate the Effects of a Single 1200mg IV Dose of Oritavancin on the Results of Multiple Coagulation Tests in Healthy Volunteers
Secondary ID [1] 0 0
MDCO-ORI-14-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Oritavancin - Subject will receive a single oritavancin dose of 1200 mg in 1000 mL of D5W administered as a constant rate IV infusion over 3 hours via a single dedicated peripheral venous line.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to resolution of elevations in coagulation test results
Timepoint [1] 0 0
up to 120 hours
Secondary outcome [1] 0 0
Changes from baseline in coagulation test results
Timepoint [1] 0 0
up to 120 hours

Eligibility
Key inclusion criteria
1. Subject is able to provide written informed consent before initiation of any study-related procedures.
2. Subject is a healthy male or female adult between 18 and 65 years of age, inclusive.
3. Subject has a body mass index (BMI) < 45 kg/m2.
4. Subject is in good health based on medical history and physical examination findings and has no clinically meaningful safety laboratory abnormalities (CBC, blood chemistry, and urinalysis) or 12-lead ECG results, as assessed by the Principal Investigator (PI).
5. Vital signs (BP, pulse and temperature) measured at screening/baseline must be within the following ranges: SBP =90 to =150 mm Hg, DBP =45 to =90 mm Hg; Heart Rate = 45 to =90 bpm (taken after resting in a supine position for at least 5 minutes).
6. Female subject is surgically sterile, postmenopausal, or, if of childbearing potential, agrees to use at least 2 acceptable methods of birth control (e.g. prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, barrier methods, abstinence) or male partner sterilization alone for the duration of the study until 60 days after study drug administration.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Has any condition, including findings in the medical history or in prestudy assessments that constitutes a risk or a contraindication for the participation in the study or completing the study.
2. Any coagulation test results that are outside of the normal range at Screening.
3. Any of the following coagulation tests results that are outside of the normal range at Baseline (Pre-Dose): Prothrombin Time/International Normalized Ratio (PT/INR), Activated clotting time (ACT), Activated Partial Thromboplastin Time (APTT).
4. Positive breath test for alcohol and/or positive urine test for drugs of abuse at Screening.
5. Has a history or presence of alcohol/drug abuse within 2 years. Alcohol abuse is defined as regularly consuming >3 units/day (21 units per week for men), >2 units/day (14 units/week) for women. A unit is defined as a can of 4% beer (330 mL), approximately 190 mL of 6-7% beer (malt liquor), a glass of 40% spirits (30 mL), a glass of wine (100 mL).
6. Blood or plasma donation within past 2 months.
7. History of hypersensitivity to drugs with a similar chemical structure (i.e. glycopeptide antibiotics) to the investigational product or any of its excipients.
8. Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 90 days prior to enrollment and/or unwilling to allow at least two months before participation in another drug trial following the current trial.
9. Treatment with any prescription or OTC drugs, within 2 weeks or five half-lives, whichever is longer, or herbal nutritional supplements within 2 weeks of screening, with the exception of acetaminophen/paracetamol for minor headache. Subjects will not be allowed to receive medications for the duration of the study (except the abovementioned acetaminophen/paracetamol). Birth control or other hormone replacement is also permitted as long as it has been taken at a stable dose for at least three months before the Screening Visit and remains stable for the duration of the study.
10. Females who are pregnant or nursing or who have a positive pregnancy test result at screening.
11. Males who are unwilling to practice abstinence or use an acceptable method of birth control during the entire study period (i.e. condom with spermicide, where locally available).

Study design
Purpose of the study
Other
Allocation to intervention
NA
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
1/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2015
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Melinta Therapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Christchurch Clinical Studies Trust Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Medical Information
Address 0 0
Melinta Therapeutics, Inc.
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/NCT02357524