TD-1607 MAD Study in Healthy Subjects

Bacterial Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949103
• Other study ID #: 0104
• Status: Completed
• Phase: Phase 1
• Start date: October 2013
• Est. completion date: July 2014

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 multiple ascending doses, will be investigated in healthy subjects to assess its tolerability, safety, and pharmacokinetics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection
• Infections

Intervention

Drug:
• TD-1607

• Placebo

Locations

Country	Name	City	State
United States	PPD, Phase 1 Clinic	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	Number of adverse events	Adverse events	17 days
Secondary	Cmax	Pharmacokinetics	17 Days
Secondary	Tmax	Pharmacokinetics	17 Days
Secondary	AUC0-t	Pharmacokinetics	17 Days
Secondary	AUC0-24	Pharmacokinetics	17 Days
Secondary	AUCinf	Pharmacokinetics	17 Days
Secondary	CL	Pharmacokinetics	17 Days
Secondary	Vdss	Pharmacokinetics	17 Days
Secondary	t1/2	Pharmacokinetics	17 Days
Secondary	Amount excreted in urine (Ae	Pharmacokinetics	17 Days
Secondary	Fraction eliminated in urine (fe)	Pharmacokinetics	17 Days
Secondary	CLr	Pharmacokinetics	17 Days
Secondary	Ctrough	Pharmacokinetics	17 Days