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Completed

NCT Number: NCT01949103

TD-1607 MAD Study in Healthy Subjects

TD-1607, administered intravenously as multiple ascending doses, will be investigated in healthy subjects to assess its tolerability, safety, and pharmacokinetics.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD, Phase 1 Clinic

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is a healthy nonsmoking male or a female (of non-childbearing potential) and 18 to 55 years old, inclusive, at Screening.
  • Subject has a body mass index (BMI) of 19 to 30 kg/m2, inclusive, and weighs at least 50 kg.

Subject has no clinically significant abnormalities in the results of laboratory evaluations at Screening and Day -1.

Exclusion criteria

  • Subject has evidence or history of clinically significant, relevant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (except for untreated, asymptomatic seasonal allergies at time of dosing).
  • Subject has a history of allergies or hypersensitivities to glycopeptide (e.g., vancomycin) or beta-lactam (e.g., penicillin or cephalosporin) antibiotics.
  • Subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives, whichever is longer) prior to Screening or is currently participating in another trial of an investigational drug (or medical device).
  • Subject has previously participated in a trial for TD-1607.

Treatment and study plan

TD-1607

Drug

Placebo

Drug

Primary outcomes

  1. Number of adverse events

    Time frame: 17 days

    Adverse events

Secondary outcomes

  1. Cmax

    Time frame: 17 Days

    Pharmacokinetics

  2. Tmax

    Time frame: 17 Days

    Pharmacokinetics

  3. AUC0-t

    Time frame: 17 Days

    Pharmacokinetics

  4. AUC0-24

    Time frame: 17 Days

    Pharmacokinetics

  5. AUCinf

    Time frame: 17 Days

    Pharmacokinetics

  6. CL

    Time frame: 17 Days

    Pharmacokinetics

  7. Vdss

    Time frame: 17 Days

    Pharmacokinetics

  8. t1/2

    Time frame: 17 Days

    Pharmacokinetics

  9. Amount excreted in urine (Ae

    Time frame: 17 Days

    Pharmacokinetics

  10. Fraction eliminated in urine (fe)

    Time frame: 17 Days

    Pharmacokinetics

  11. CLr

    Time frame: 17 Days

    Pharmacokinetics

  12. Ctrough

    Time frame: 17 Days

    Pharmacokinetics

Sponsors and collaborators

Lead sponsor

Theravance Biopharma

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1607, a Glycopeptide-Cephalosporin Heterodimer Antibiotic, in Healthy Subjects

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 24, 2013
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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