Safety and Pharmacokinetic (PK) Study to Assess Bronchopulmonary Disposition of IV Eravacycline (TP-434) in Healthy Men and Women

NCT01989949 | Completed Phase 1

• 1 other identifier: TP-434-006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 1, open-label, randomized pharmacokinetic and safety study in healthy adult subjects, who will undergo bronchoscopy and bronchoalveolar lavage (BAL) after receiving seven (7) doses of 1.0 mg/kg IV TP-434.

Conditions

Normal Drug Tolerance

Outcome Measures

Primary Outcomes (1)

• To determine the steady-state plasma pharmacokinetics and disposition of TP-434 into the epithelial lining fluid (ELF) and alveolar macrophages (AM) of healthy adult subjects after intravenous (IV) administration.

  End of Therapy (Day 4)

Secondary Outcomes (1)

• To determine the safety and tolerability of TP-434 in healthy adult subjects based primarily on the incidence, intensity and type of adverse events (AEs), clinical laboratory assessments, physical examinations, vital signs, and 12-lead ECGs.

  Screening Visit through Day 20

Study Arms (1)

TP-434 (Eravacycline) via IV infusion

EXPERIMENTAL

TP-434 (Eravacycline) reconstituted and administered via IV infusion at a dose of 1 mg/kg, every 12 hours, for 7 doses over 4 days.

Drug: TP-434 (Eravacycline) reconstituted and administered via an IV infusion

Interventions

TP-434 (Eravacycline) reconstituted and administered via an IV infusion DRUG

TP-434 (Eravacycline) via IV infusion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males or non-pregnant, non-lactating healthy females
• Age \>18 to ≤ 65 years of age, inclusive
• Body mass index of 18 to 33 kg/m2 or, if outside the range, considered not clinically significant by the Investigator
• Must be willing and able to communicate and participate in the whole study
• Must provide written informed consent
• Must agree to use adequate methods of contraception

You may not qualify if:

• Participation in a clinical research study within the previous 3 months
• Subjects who have previously received TP-434
• History of any drug or alcohol abuse in the past 2 years
• Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
• Current smokers and those who have smoked within the last 6 months.
• Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the Investigator at screening
• Clinically significant abnormal biochemistry, haematology, coagulation or urinalysis as judged by the Investigator
• Positive tests for drugs of abuse
• Positive hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV; I and II) results
• History of chronic respiratory disorders as judged by the Investigator
• Serious adverse reaction or serious hypersensitivity to tetracyclines, midazolam or like compound, lidocaine or like compounds, or the formulation excipients
• Donation or loss of greater than 400 mL of blood within the previous 3 months
• Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (with the exception of anti inflammatory, anti-hypertensive medications, or hormone replacement therapy) in the 14 days before Investigational Medicinal Product administration unless judged to not interfere with the study objectives according to the Investigator and sponsor's medical monitor
• Failure to satisfy the Investigator of fitness to participate for any other reason

Sponsors & Collaborators

• Tetraphase Pharmaceuticals, Inc: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

Center for Anti-infective Research and Development; Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Related Publications (1)

• Ji X-w, Mak WY, Xue F, Yang W-y, Kuan IH-S, Xiang X-q, Li Y, Zhu X. Population pharmacokinetics and pulmonary modeling of eravacycline and the determination of microbiological breakpoint and cutoff of PK/PD. Antimicrob Agents Chemother. 2025 Mar 5;69(3):e0106524. doi: 10.1128/aac.01065-24. Epub 2025 Jan 29.

  PMID: 39878492 DERIVED

MeSH Terms

Interventions

eravacycline

Study Officials

• Patrick T Horn, MD, PhD

  Tetraphase Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: November 21, 2013
• Study Start: November 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2013
• Last Updated: December 17, 2021

Record last verified: 2021-12

Locations

US (1)