TD-1607 SAD Study in Healthy Subjects

Serious Infections Due to Known or Suspected Gram-positive Pathogens Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791049
• Other study ID #: 0098
• Status: Completed
• Phase: Phase 1
• Start date: April 2013
• Est. completion date: October 2013

Study information

• Verified date: January 2021
• Source: Theravance Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Subject is a healthy nonsmoking male or a female of non-child bearing potential and 18 to 50 years old, inclusive, at Screening. Females are considered to be of non-childbearing potential if they have had a hysterectomy or tubal ligation or are postmenopausal (amenorrheic for at least 2 years) with a follicle-stimulating hormone (FSH) level >20 IU/L.

• Subject has a body mass index (BMI) of 19 to 30 kg/m2, inclusive, and weighs at least 50 kg

Exclusion Criteria:

• Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.

• Subject has a history of allergies or hypersensitivities to glycopeptide (e.g., vancomycin), 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).

Related Conditions & MeSH terms

• Infection
• Serious Infections Due to Known or Suspected Gram-positive Pathogens

Intervention

Drug:
• TD-1607

• Placebo

Locations

Country	Name	City	State
United States	PPD Phase 1	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability	Adverse events, laboratory abnormalities, ECGs, and vital sign measurements.	11 days
Secondary	Pharmacokinetics	Cmax, Tmax, AUC0-t, AUC0-24, AUCinf, CL, Vdss, t1/2, amount excreted in urine (Ae), fraction eliminated in urine (fe), and CLr.	96 hours