TD-1607 MAD Study in Healthy Subjects

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov Identifier:
NCT01949103
First received: September 17, 2013
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Infections
Bacterial Infections
Drug: TD-1607
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Theravance Biopharma Antibiotics, Inc.:

Primary Outcome Measures:
  • Number of adverse events [ Time Frame: 17 days ] [ Designated as safety issue: Yes ]
    Adverse events


Secondary Outcome Measures:
  • Cmax [ Time Frame: 17 Days ] [ Designated as safety issue: No ]
    Pharmacokinetics

  • Tmax [ Time Frame: 17 Days ] [ Designated as safety issue: No ]
    Pharmacokinetics

  • AUC0-t [ Time Frame: 17 Days ] [ Designated as safety issue: No ]
    Pharmacokinetics

  • AUC0-24 [ Time Frame: 17 Days ] [ Designated as safety issue: No ]
    Pharmacokinetics

  • AUCinf [ Time Frame: 17 Days ] [ Designated as safety issue: No ]
    Pharmacokinetics

  • CL [ Time Frame: 17 Days ] [ Designated as safety issue: No ]
    Pharmacokinetics

  • Vdss [ Time Frame: 17 Days ] [ Designated as safety issue: No ]
    Pharmacokinetics

  • t1/2 [ Time Frame: 17 Days ] [ Designated as safety issue: No ]
    Pharmacokinetics

  • Amount excreted in urine (Ae [ Time Frame: 17 Days ] [ Designated as safety issue: No ]
    Pharmacokinetics

  • Fraction eliminated in urine (fe) [ Time Frame: 17 Days ] [ Designated as safety issue: No ]
    Pharmacokinetics

  • CLr [ Time Frame: 17 Days ] [ Designated as safety issue: No ]
    Pharmacokinetics

  • Ctrough [ Time Frame: 17 Days ] [ Designated as safety issue: No ]
    Pharmacokinetics


Estimated Enrollment: 48
Study Start Date: October 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TD-1607 or placebo (Dose1)
TD-1607 or placebo administered intravenously
Drug: TD-1607 Drug: Placebo
Experimental: TD-1607 or placebo (Dose 2)
TD-1607 or placebo administered intravenously
Drug: TD-1607 Drug: Placebo
Experimental: TD-1607 or placebo (Dose 3)
TD-1607 or placebo administered intravenously
Drug: TD-1607 Drug: Placebo
Experimental: TD-1607 or placebo (Dose 4)
TD-1607 or placebo administered intravenously
Drug: TD-1607 Drug: Placebo
Experimental: TD-1607 or placebo (Dose 5) [Optional]
TD-1607 or placebo administered intravenously
Drug: TD-1607 Drug: Placebo
Experimental: TD-1607 or placebo (Dose 6) [Optional]
TD-1607 or placebo administered intravenously
Drug: TD-1607 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01949103

Locations
United States, Texas
PPD, Phase 1 Clinic
Austin, Texas, United States, 78744
Sponsors and Collaborators
Theravance Biopharma Antibiotics, Inc.
  More Information

No publications provided

Responsible Party: Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov Identifier: NCT01949103     History of Changes
Other Study ID Numbers: 0104
Study First Received: September 17, 2013
Last Updated: November 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Theravance Biopharma Antibiotics, Inc.:
Gram-positive

Additional relevant MeSH terms:
Bacterial Infections

ClinicalTrials.gov processed this record on August 28, 2014