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
NCT number | NCT01949103 |
Other study ID # | 0104 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | October 2013 |
Est. completion date | July 2014 |
Verified date | January 2021 |
Source | Theravance Biopharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
TD-1607, administered intravenously as multiple ascending doses, will be investigated in healthy subjects to assess its tolerability, safety, and pharmacokinetics.
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. |
Country | Name | City | State |
---|---|---|---|
United States | PPD, Phase 1 Clinic | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
Theravance Biopharma |
United States,
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 |
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