Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 (Biapenem) in Healthy Adult Subjects

NCT01702649 | Completed Phase 1

• 1 other identifier: Rempex 401
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

RPX2003 (biapenem) is being studied in combination with a beta-lactamase inhibitor to treat bacterial infections, including those due to multi-drug resistant bacteria.

Conditions

Healthy Volunteers; Bacterial Infections

Outcome Measures

Primary Outcomes (1)

• Safety from baseline through the end of the study.

  Number of patients with adverse events; assessed by patient reporting, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.

  Study Day 1 to 13.

Secondary Outcomes (2)

• Composite of PK parameters RPX2003 & placebo following single dose administration.

  Part 1A Study Day 1 to 3.

• Composite of PK parameters RPX2003 & placebo following multiple dose administration.

  Part 1B Day 4 to 12

Study Arms (2)

RPX2003 (Biapenem)

EXPERIMENTAL

Single and multiple dose of RPX2003 (Biapenem).

Drug: RPX2003 (Biapenem)

Normal Saline

PLACEBO COMPARATOR

Single and multiple doses of normal saline.

Drug: Placebo

Interventions

RPX2003 (Biapenem) DRUG

Six (6) cohorts of 3 active or 8 subjects of 6 active are planned for evaluation. Single dose followed by multiple dose, three times a day.

RPX2003 (Biapenem)

Placebo DRUG

Six (6) cohorts of 1 placebo or 8 subjects of 2 placebo are planned for evaluation. Single dose followed by multiple dose, three times a day.

Normal Saline

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult males and/or females, 18 to 55 years of age
• Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).
• Medically healthy with clinically insignificant screening results
• Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to Day 1.
• Sexually abstinent or use acceptable methods of birth control

You may not qualify if:

• History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
• History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
• Hypersensitivity or idiosyncratic reaction to compounds related to the study drug (e.g. beta-lactam antibiotics such as penicillins, carbapenems, etc).
• History of seizures (e.g., epilepsy).
• Use of any over-the-counter (OTC) medication, including herbal products and vitamins, within the 7 days prior to Day 1. Up to 2 grams per day of acetaminophen is allowed for acute events at the discretion of the PI.
• Blood donation or significant blood loss (i.e., \> 500 mL) within 56 days prior to Day 1.
• Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).

Sponsors & Collaborators

• Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company): lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

biapenem

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Jeff Loutit, MBChB

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: October 8, 2012
• Study Start: August 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 3, 2012

Record last verified: 2012-11

Locations

US (1)