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

16 december 2021 uppdaterad av: Tetraphase Pharmaceuticals, Inc.

Phase 1, Open-Label, Safety and Pharmacokinetic Study to Assess Bronchopulmonary Disposition of Intravenous TP-434 in Healthy Men and Women

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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. Dosing will be twice daily (q12h) for three consecutive days beginning on day one (1) and a morning dose on day four (4).

Approximately 20 subjects will be enrolled into the study at one (1) investigational site. The population for this study is healthy male and female subjects 18 to 65 years of age.

This study includes a Screening Period of up to 30 days, a 4 day, open-label Treatment Period, and a two week Follow-up Period. There will be one 6 day/5 night inpatient stay (Days -1 to 5) during the Treatment Period and one outpatient visit at the end of the Follow-up Period. Excluding the Screening Period, the total duration of confinement (in the Clinical Research Center) will be approximately six (6) days and the total study duration, not including screening, will be approximately three (3) weeks.

Participants will be admitted to the Clinical Research Center on Day -1. Participants will receive four (4) days of intravenous TP-434 1.0 mg/kg of body weight twice daily (q12h) for three consecutive days and a morning dose on day four (4) (for a total of 7 doses) starting on Day 1. Blood and urine samples, ECGs, and vital signs will be collected for safety analysis at specified time points.

Pharmacokinetic blood sampling will occur on Day 4before and after the Day 4 dose of TP-434 at specified time points.

Participants will be randomized to a single BAL procedure time point. Bronchoscopy and BAL will be performed at the following time points after dosing of TP-434 on Day 4: two (2), four (4), six (6), and 12 hours after start of infusion. Bronchoscopy and BAL will be conducted for up to five (5) different participants at each time point. Each subject will undergo bronchoscopy and BAL only once.

Studietyp

Interventionell

Inskrivning (Faktisk)

20

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Connecticut
      • Hartford, Connecticut, Förenta staterna, 06102
        • Center for Anti-infective Research and Development; Hartford Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

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

Exclusion Criteria:

  1. Participation in a clinical research study within the previous 3 months
  2. Subjects who have previously received TP-434
  3. History of any drug or alcohol abuse in the past 2 years
  4. 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)
  5. Current smokers and those who have smoked within the last 6 months.
  6. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the Investigator at screening
  7. Clinically significant abnormal biochemistry, haematology, coagulation or urinalysis as judged by the Investigator
  8. Positive tests for drugs of abuse
  9. Positive hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV; I and II) results
  10. History of chronic respiratory disorders as judged by the Investigator
  11. Serious adverse reaction or serious hypersensitivity to tetracyclines, midazolam or like compound, lidocaine or like compounds, or the formulation excipients
  12. Donation or loss of greater than 400 mL of blood within the previous 3 months
  13. 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
  14. Failure to satisfy the Investigator of fitness to participate for any other reason

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: TP-434 (Eravacycline) via IV infusion
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.
Läkemedel: TP-434 (Eravacycline) reconstituted and administered via an IV infusion

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
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.
Tidsram: End of Therapy (Day 4)
End of Therapy (Day 4)

Sekundära resultatmått

Resultatmått
Tidsram
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.
Tidsram: Screening Visit through Day 20
Screening Visit through Day 20

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Tetraphase Pharmaceuticals, Inc.

Samarbetspartners

Department of Health and Human Services

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 2012

Primärt slutförande (Faktisk)

1 januari 2013

Avslutad studie (Faktisk)

1 april 2013

Studieregistreringsdatum

Först inskickad

10 september 2013

Först inskickad som uppfyllde QC-kriterierna

20 november 2013

Första postat (Uppskatta)

21 november 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 december 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 december 2021

Senast verifierad

1 december 2021

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • TP-434-006

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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Platser

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