Status:
COMPLETED
A Phase 1 Safety and PK Study of IV TP-271
Lead Sponsor:
Tetraphase Pharmaceuticals, Inc
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Bacterial Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This is a single-center, randomized, placebo-controlled, double-blind, multiple-ascending-dose, inpatient study to assess the safety, tolerability, and pharmacokinetics of TP-271 in healthy subjects. ...
Detailed Description
Up to 5 cohorts of 8 subjects each (up to a total of 40 subjects) will be enrolled. The 8 subjects within each cohort will be randomized 6:2 to receive multiple IV doses of TP-271 or placebo. Study dr...
Eligibility Criteria
Inclusion
- Be within the age range of 18 to 50 years, inclusive, at the time of Screening
- Voluntarily sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved ICF to participate in the study after all relevant aspects of the study have been explained and discussed with the subject and before undergoing any study-related procedures
- Have a body mass index (BMI) ≥18.0 and ≤33.0 kg/m2
- Have a negative history of and negative screening results for human immunodeficiency virus 1 and 2 and hepatitis B and C antibodies
- Have the ability to communicate with the study unit staff in a manner sufficient to carry out all protocol procedures as described
- For female subjects, be of non-childbearing potential, either 1 year postmenopausal or surgically sterile (bilateral oophorectomy, bilateral tubal ligation, or complete hysterectomy)
- For male subjects, be willing and able to use a barrier method of contraception or practice abstinence (including males who had a vasectomy) from dosing through 90 days after administration of the final dose of study drug
Exclusion
- History and/or presence of any clinically significant disease or disorder such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal, endocrine, psychiatric, or mental disease or disorder, or mental or legal incapacitation, which, in the opinion of the PI or Sub-Investigator(s), may either put the subject at risk because of participation in the study, influence the results of the study, or influence the subject's ability to participate in the study
- Clinical laboratory values that fall outside the eligibility range specified in Appendix D; for laboratory values that are not included in Appendix D, values outside the reference range are exclusionary, with the following exceptions (Table 4. Acceptable Out-of-Range Clinical Laboratory Values
- Known allergy to tetracycline antibiotics or to any of the excipients in TP-271
- Clinically significant abnormality on a 12-lead ECG, including the following:
- Rhythm other than sinus
- Corrected QT interval using Fridericia's formula (QTcF) \>450 msec
- Evidence of second- or third-degree atrioventricular block
- Pathological Q-waves (defined as Q-wave \>40 msec or depth \>0.4 to 0.5 mV)
- Evidence of ventricular pre-excitation
- Evidence of complete left bundle branch block (BBB), right BBB, or incomplete left BBB
- Intraventricular conduction delay with QRS duration \>120 msec
- ST segment abnormalities, unless judged by the PI or Sub-Investigator(s) to be non pathologic
- History of seizures
- History within 3 years of a positive result on a urine screen for drugs of abuse or a positive result at Screening for any of the following drugs of abuse: tetrahydrocannabinols, cocaine, opioids, phencyclidines, amphetamine, benzodiazepine, and barbiturates
- Use of tobacco, nicotine, or nicotine-replacement products within 3 months prior to administration of the study drug through the last visit
- Typical weekly alcohol consumption of 7 or more alcoholic drinks, where 1 alcoholic drink is defined as 1 glass of beer (approximately 10 to 12 oz), 1 can (12 oz) of beer, 1 glass of wine (approximately 4 to 5 oz), or distilled spirits (approximately 1 oz or 30 mL of liquor)
- Alcohol consumption within 48 hours prior to dosing
- Participation in a clinical study within 10 half-lives of the prior study drug administration or within the previous 3 months if the half-life or dose of the investigational agent is unknown or planned participation in another clinical study concurrent with the current clinical study
- History of difficulty donating blood or poor venous access
- Blood donation (1 unit or approximately 350 mL) within 1 month prior to receiving study drug or plans to donate prior to receiving study drug or during the clinical study
- Use of any prescription or nonprescription medication, including vitamins or herbal medications, vaccination, or immunization within 7 days or 5 half-lives (if known), whichever is longer, prior to dosing of study drug, with the following exceptions: medications used to treat an AE, and the use of acetaminophen, naproxen, and ibuprofen (except for within 24 hours prior to dosing)
- Male subject donates or plans to donate sperm during the study and for at least 90 days after study drug administration.
- Unwillingness or inability to follow the procedures outlined in the clinical study protocol
Key Trial Info
Start Date :
August 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03234738
Start Date
August 16 2017
End Date
January 2 2018
Last Update
December 13 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
PPD Phase 1 Clinic
Austin, Texas, United States, 78744