Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients

NCT03873987 | Completed Phase 1 Results FDA Drug

• 1 other identifier: ML-ORI-102
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 4

Brief Summary

This study is being conducted to evaluate the pharmacokinetic (PK) and safety of Kimyrsa versus the approved oritavancin formulation in subjects with acute bacterial skin and skin structure infection (ABSSSI). Kimyrsa adjusts the infusion time, concentration and reconstitution/administration solutions of a single 1200 mg intravenous (IV) infusion of oritavancin

Conditions

Acute Bacterial Skin and Skin Structure Infection

Outcome Measures

Primary Outcomes (2)

• Relative Exposure of AUC of the New Formulation to the Approved Formulation

  Relative exposure of AUC of the new formulation to the approved formulation of oritavancin based on area under the plasma concentration-time curve from time zero to 72 hr (AUC0-72)

  72 hours

• Relative Exposure of AUC of the New Formulation to the Approved Formulation

  Relative exposure of AUC of the new formulation to the approved formulation of oritavancin based on area under the plasma concentration-time curve from time zero to 168 hr (AUC0-168).

  168 hours (Day 8)

Secondary Outcomes (1)

• Number of Subjects With at Least One Treatment Emergent Adverse Event (TEAE)

  336 hours (Day 15)

Study Arms (2)

Current Formulation of Oritavancin

ACTIVE COMPARATOR

Three single-use vials, each containing 400 mg (1200 mg total) of oritavancin diphosphate (as the free base) and the inactive component mannitol. Oritavancin vials will be reconstituted with SWFI and further diluted in D5W for a total volume of 1000 mL and infused intravenously over 3 hours.

Drug: Current Formulation of Oritavancin

Kimyrsa

EXPERIMENTAL

A single vial containing 1200 mg of oritavancin, HPβCD, and mannitol. Kimyrsa vials will be reconstituted with SWFI and further diluted with 0.9% sodium chloride for a total volume of 250 mL and infused intravenously over 1 hour.

Drug: Kimyrsa

Interventions

Current Formulation of Oritavancin DRUG

Current formulation of oritavancin (3 hour infusion of 1200 mg in 1000 ml of D5W)

Also known as: Orbactiv

Current Formulation of Oritavancin

Kimyrsa DRUG

New formulation of oritavancin (1 hour infusion of 1200 mg in 250 ml of saline)

Kimyrsa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects may be included in the study if they meet all of the following criteria:
• Subject must be 18 years of age or older, male or female, and of any race.
• Subject must give written informed consent before initiation of any study-related procedures.
• Diagnosis of ABSSSI (wound infections, cellulitis/erysipelas, or cutaneous abscess) suspected or confirmed to be caused by a Gram-positive pathogen requiring IV therapy.
• If female, the subject is surgically sterile, postmenopausal, or, if of childbearing potential, agrees to use at least 2 highly effective methods of birth control (e.g. prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, barrier methods, abstinence) for the duration of the study until 60 days after study drug administration, or male partner sterilization alone.
• Subject must express a commitment to comply with all study visits, procedures and requirements for the duration of the study.

You may not qualify if:

• Infections associated with, or in close proximity to, a prosthetic device.
• Severe sepsis or refractory shock.
• Known or suspected bacteremia at time of screening.
• ABSSSI due to or associated with any of the following:
• Infections suspected or documented to be caused by only Gram-negative pathogens (i.e., infections acquired during prolonged admission in hospital or long-term care facilities).
• Diabetic foot infections (infection extending distal to the malleoli in a subject with diabetes mellitus and peripheral neuropathy and/or vascular insufficiency or any ulceration of their foot).
• Concomitant infection at another site not including a secondary ABSSSI lesion (e.g., septic arthritis, endocarditis, osteomyelitis).
• Infected burns.
• A primary infection secondary to a pre-existing skin disease with associated inflammatory changes such as atopic dermatitis, eczema, or hidradenitis suppurativa.
• Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease (arterial or venous).
• Any evolving necrotizing process (i.e., necrotizing fasciitis), gangrene or infection suspected or proven to be caused by Clostridium species (e.g., crepitance on examination of the ABSSSI site and/or surrounding tissue(s) or radiographic evidence of subcutaneous gas in proximity to the infection).
• Infections known to be caused by an organism resistant to oritavancin.
• Catheter site infections.
• Treatment with investigational medicinal product within 30 days or 5 half-lives, whichever is longer, before enrollment and for the duration of the study.
• Subjects currently receiving anticoagulant therapy.

Sponsors & Collaborators

• Melinta Therapeutics, Inc.: lead

Study Sites (4)

ML-ORI-102 Study Site

Chula Vista, California, 91911, United States

Location

ML-ORI-102 Study Site

La Mesa, California, 91942, United States

Location

ML-ORI-102 Study Site

Burr Ridge, Illinois, 60527, United States

Location

ML-ORI-102 Study Site

Somers Point, New Jersey, 08244, United States

Location

MeSH Terms

Interventions

oritavancin

Results Point of Contact

• Title: Vice President Clinical Operations
• Organization: Melinta Therapeutics, Inc.

kfusaro@melinta.com

9086171319

Study Officials

• Sue K Cammarata, MD

  Melinta Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 14, 2019
• Study Start: July 16, 2019
• Primary Completion: August 27, 2019
• Study Completion: September 4, 2019
• Last Updated: April 13, 2021
• Results First Posted: April 13, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)