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TD-1607 MAD Study in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01949103
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : September 4, 2014
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Infections Bacterial Infections Drug: TD-1607 Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2013
Primary Completion Date : June 2014
Study Completion Date : July 2014
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: 17 days ]
    Adverse events


Secondary Outcome Measures :
  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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01949103


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

Responsible Party: Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov Identifier: NCT01949103     History of Changes
Other Study ID Numbers: 0104
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: September 4, 2014
Last Verified: September 2014

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bacterial Infections