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TD-1607 MAD Study in Healthy Subjects

Primary Purpose

Infections, Bacterial Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TD-1607
Placebo
Sponsored by
Theravance Biopharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infections focused on measuring Gram-positive

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • PPD, Phase 1 Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

TD-1607 or placebo (Dose1)

TD-1607 or placebo (Dose 2)

TD-1607 or placebo (Dose 3)

TD-1607 or placebo (Dose 4)

TD-1607 or placebo (Dose 5) [Optional]

TD-1607 or placebo (Dose 6) [Optional]

Arm Description

TD-1607 or placebo administered intravenously

TD-1607 or placebo administered intravenously

TD-1607 or placebo administered intravenously

TD-1607 or placebo administered intravenously

TD-1607 or placebo administered intravenously

TD-1607 or placebo administered intravenously

Outcomes

Primary Outcome Measures

Number of adverse events
Adverse events

Secondary Outcome Measures

Cmax
Pharmacokinetics
Tmax
Pharmacokinetics
AUC0-t
Pharmacokinetics
AUC0-24
Pharmacokinetics
AUCinf
Pharmacokinetics
CL
Pharmacokinetics
Vdss
Pharmacokinetics
t1/2
Pharmacokinetics
Amount excreted in urine (Ae
Pharmacokinetics
Fraction eliminated in urine (fe)
Pharmacokinetics
CLr
Pharmacokinetics
Ctrough
Pharmacokinetics

Full Information

First Posted
September 17, 2013
Last Updated
January 15, 2021
Sponsor
Theravance Biopharma
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1. Study Identification

Unique Protocol Identification Number
NCT01949103
Brief Title
TD-1607 MAD Study in Healthy Subjects
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 Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theravance Biopharma

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Bacterial Infections
Keywords
Gram-positive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TD-1607 or placebo (Dose1)
Arm Type
Experimental
Arm Description
TD-1607 or placebo administered intravenously
Arm Title
TD-1607 or placebo (Dose 2)
Arm Type
Experimental
Arm Description
TD-1607 or placebo administered intravenously
Arm Title
TD-1607 or placebo (Dose 3)
Arm Type
Experimental
Arm Description
TD-1607 or placebo administered intravenously
Arm Title
TD-1607 or placebo (Dose 4)
Arm Type
Experimental
Arm Description
TD-1607 or placebo administered intravenously
Arm Title
TD-1607 or placebo (Dose 5) [Optional]
Arm Type
Experimental
Arm Description
TD-1607 or placebo administered intravenously
Arm Title
TD-1607 or placebo (Dose 6) [Optional]
Arm Type
Experimental
Arm Description
TD-1607 or placebo administered intravenously
Intervention Type
Drug
Intervention Name(s)
TD-1607
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of adverse events
Description
Adverse events
Time Frame
17 days
Secondary Outcome Measure Information:
Title
Cmax
Description
Pharmacokinetics
Time Frame
17 Days
Title
Tmax
Description
Pharmacokinetics
Time Frame
17 Days
Title
AUC0-t
Description
Pharmacokinetics
Time Frame
17 Days
Title
AUC0-24
Description
Pharmacokinetics
Time Frame
17 Days
Title
AUCinf
Description
Pharmacokinetics
Time Frame
17 Days
Title
CL
Description
Pharmacokinetics
Time Frame
17 Days
Title
Vdss
Description
Pharmacokinetics
Time Frame
17 Days
Title
t1/2
Description
Pharmacokinetics
Time Frame
17 Days
Title
Amount excreted in urine (Ae
Description
Pharmacokinetics
Time Frame
17 Days
Title
Fraction eliminated in urine (fe)
Description
Pharmacokinetics
Time Frame
17 Days
Title
CLr
Description
Pharmacokinetics
Time Frame
17 Days
Title
Ctrough
Description
Pharmacokinetics
Time Frame
17 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Theravance Biopharma
Official's Role
Study Director
Facility Information:
Facility Name
PPD, Phase 1 Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States

12. IPD Sharing Statement

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TD-1607 MAD Study in Healthy Subjects

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