Bacterial InfectionsPhase 1NCT03450187
A Phase 1 TP-271 Oral PK Multiple Ascending Dose Study
A Phase 1 study testing TP-271 in people with Bacterial Infections, run by Tetraphase Pharmaceuticals, Inc at 1 site in United States.
Trial summary
This is a phase 1, single-center, randomized, placebo-controlled, double-blind, multiple ascending-dose study to assess the safety, tolerability, and PK of oral TP-271 in healthy adult subjects. Male or female subjects aged 18 to 50 years who fulfill the inclusion/exclusion criteria will be enrolled in this study. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- TP-271
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2018to 31 Mar 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 to 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 (HIV) types 1 and 2 and hepatitis B and C
- Have the ability to communicate with the study unit staff in a manner sufficient to carry out all protocol procedures as described
- Female subjects must be of non-childbearing potential, either 1-year postmenopausal or surgically sterile (i.e., bilateral oophorectomy, bilateral tubal ligation, or complete hysterectomy)
- Male subjects must be willing and able to use a barrier method of contraception or practice abstinence (including male subjects who had a vasectomy) from dosing to 90 days after final administration of the study drug
Who cannot join
- 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, may either put the subject at risk due to 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 of the eligibility range specified in Appendix D are exclusionary; for clinical laboratory values that are not included in Appendix D, values outside of the reference range are exclusionary, except for those parameters listed in Table 4).
- Table 4 Acceptable Out-of-Range Clinical Laboratory Values
- Low Chemistry Values:
- Bicarbonate (a) Chloride GGT HDL cholesterol LDH LDL cholesterol Phosphorus
- High Chemistry Values:
Show all 32Show fewer
- Chloride HDL cholesterol LDL cholesterol Phosphorus Triglycerides
- Out-of-Range Urinalysis Values; High or low specific gravity Cloudy Mucus Crystals Ketones (b) Hyaline casts High or low pH Urobilinogen (c)
- Out of Range Hematology Values; High hematocrit Basophils Monocytes MCV MCH MCHC RBC
- a Bicarbonate >18 mEq/L. b Acceptable only when the concurrent blood glucose is normal. c Measured when monitoring the serum bilirubin concentration. Abbreviations: GGT = gamma-glutamyltransferase; HDL = high-density lipoprotein; LDH = lactate dehydrogenase; LDL = low-density lipoprotein; MCH = mean corpuscular hemoglobin; MCHC = mean corpuscular hemoglobin concentration; MCV = mean corpuscular volume; RBC = red blood cell.
- Known allergy to tetracycline antibiotics or any of the excipients in TP 271
- Clinically significant abnormality on a 12-lead ECG, which includes the following:
- Rhythm other than sinus
- Corrected QT interval using Fridericia's formula (QTcF) >450 msec
- Evidence of second- or third-degree atrioventricular (AV) block
- Pathological Q-waves (defined as a 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 to be nonpathologic
- History of seizures
- History within 3 years of a positive result on a urine screen for drugs of abuse or a positive result on a urine screen at Screening for any of the following drugs of abuse: tetrahydrocannabinols, cocaine, opioids, phencyclidines, amphetamines, benzodiazepines, barbiturates, and cotinine
- Use of tobacco, nicotine, or nicotine-replacement products within 3 months prior to initial administration of study drug to the EOS 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 of beer (12 oz), 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 admission
- Participation in a clinical study within 10 half-lives of the prior study treatment or within the previous 3 months (if the half-life of investigational agent is unknown) prior to initial administration of study drug or planned participation in another clinical study concurrent with the present study
- History of difficulty donating blood or poor venous access
- Recent blood donation (1 unit or approximately 525 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 initial administration of study drug, with the following exceptions: medications used to treat an AE are permitted, and the use of acetaminophen, naproxen, and ibuprofen is permitted, except for within 24 hours prior to dosing
- Male subjects who donate or plan to donate sperm during the study or within 90 days after final administration of the study drug
- Unwillingness or inability to follow the procedures outlined in the clinical study protocol
- Previous participation in another TP-271 study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral TP-271 in Healthy Adult Subjects
This is a phase 1, single-center, randomized, placebo-controlled, double-blind, multiple ascending-dose study to assess the safety, tolerability, and PK of oral TP-271 in healthy adult subjects. Male or female subjects aged 18 to 50 years who fulfill the inclusion/exclusion criteria will be enrolled in this study.
Read the detailed description
This is a phase 1, single-center, randomized, placebo-controlled, double-blind, multiple ascending-dose study to assess the safety, tolerability, and PK of oral TP-271 in healthy adult subjects. Male or female subjects aged 18 to 50 years who fulfill the inclusion/exclusion criteria will be enrolled in this study.
Up to 5 cohorts of 8 subjects each (up to a total of 40 subjects) will be enrolled. Subjects in each cohort will be randomized 6:2 to receive multiple oral doses of TP 271 or placebo. Every effort will be made to dose all subjects in a cohort on the same day.
Doses of study drug will be administered orally either once daily in the morning or twice daily in the morning and evening from Days 1 to 7. In all subjects, the morning dose will be administered following an overnight fast (minimum 8 hours) of food and all beverages, except for water. For subjects in Cohorts D and E only, the evening dose will be administered following a minimum 3-hour fast of food and all beverages, except for water. Fasting in all cohorts will continue for at least 2 hours following each study drug administration.
During the Screening Period (within 28 days prior to the subject receiving study drug), each subject will be assessed for eligibility. Each subject must sign and date an ICF prior to undergoing any study-related procedures.
- Conditions
- Bacterial Infections
- Being tested
- TP-271
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP-271Drug
multiple oral doses of TP-271 or placebo, randomized 6:2, doses escalating 50 mg, 100 mg, 200 mg, 300 mg, 400 mg once daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Active comparator | 50 mg TP-271 q24 (n=6), a novel, broad-spectrum tetracycline-class antibiotic or matching placebo (n=2) once daily for 7 days. Receives: Drug: TP-271 |
| Cohort B | Active comparator | 100 mg TLP-271 q24 (n=6), a novel, broad spectrum tetracycline-class antibiotic or matching placebo (n=2) once daily for 7 days. Receives: Drug: TP-271 |
| Cohort C | Active comparator | 200 mg TP-271 q24 (n=6), a novel, broad spectrum tetracycline-class antibiotic or matching placebo (n=2) once daily for 7 days. Receives: Drug: TP-271 |
| Cohort D | Active comparator | 300 mg TP-271 q24 (n=6), a novel, broad spectrum tetracycline-class antibiotic or matching placebo (n=2) once daily for 7 days. Receives: Drug: TP-271 |
| Cohort E | Active comparator | 400 mg TP-271 q24 (n=6), a novel, broad spectrum tetracycline-class antibiotic or matching placebo (n=2) once daily for 7 days. Receives: Drug: TP-271 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Incidence, intensity, and type of adverse events.
Measured: From the time of signing of the informed consent form throughout study completion (approximately 39 days)
A Directed Physical Examination including chest/respiratory
changes in physical examination findings for chest/respiratory
Measured: Day -1 to the End of Study visit, Day 21
A Directed Physical Examination including heart/cardiovascular
Changes in Physical Examination including heart/cardiovascular
Measured: Day -1 to the End of study visit, Day 21
Vital Signs including Pulse Rate
Changes in Pulse Rate
Measured: Day -1 to the End of study visit, Day 21
Vital Signs including respiration rate
Changes in respiration rate
Measured: Day -1 to the End of study visit, Day 21
Vital Signs including body temperature
Changes in body temperature
Measured: Day -1 to the end of study visit, Day 21
Vital Signs including blood pressure
Changes in blood pressure
Measured: Day -1 to the End of study visit, Day 21
ECG measurements including PR interval
Changes in PR interval > or=20
Measured: Day -1 to the End of study visit, Day 21
ECG measurements including QRS interval
Changes in QRS interval> or=10
Measured: Day -1 to the end of study visit, Day 21
ECG measurements including QTcF interval
Changes in QTcF interval 30 to 60, > or =60
Measured: Day -1 to the end of study visit, Day 21
Safety Laboratory results including clinical chemistry
Changes in safety laboratory results including clinical chemistry
Measured: Day -1 to the End of study visit, Day 21
Safety Laboratory results including electrolytes
Changes in safety laboratory results including electrolytes
Measured: Day -1 to the End of study visit, Day 21
Safety Laboratory results including hematology
Changes in safety laboratory results including hematology
Measured: Day -1 to the End of study visit, Day 21
Safety Laboratory results including blood glucose
Changes in Safety laboratory results including glucose
Measured: Day -1 to the End of study visit, Day 21
Safety Laboratory results including coagulation
Changes in Safety Laboratory results including coagulation
Measured: Day -1 to the End of study visit, Day 21
Secondary outcomes (12)
Plasma concentrations
Plasma concentrations of TP-271 and its C-4 epimer TP-9555 for PK analysis
Measured: Days 1-7
Urine pharmacokinetics
Urine concentrations of TP-271 and it's C-4 epimer, TP-9555
Measured: Days 1-7
PK parameters - Cmax
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for Cmax (the maximum observed plasma concentration)
Measured: Days 1-7
PK parameters- Tmax
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for Tmax
Measured: Days 1-7
PK parameters AUC (0-last)
Area under the concentration versus time curve (AUC) from time zero to the last measured time point
Measured: Days 1-7
PK parameters - AUC (0-inf)
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for AUC (0-inf) (The area under the concentration vs time curve from time zero extrapolated to infinity)
Measured: Days 1-7
PK parameters- AUC% extrapolated
PL parameters will be calculated from the plasma concentration versus time data (as appropriate) for AUC% extrapolated (the percentage of AUC 90-inf) accounted for by extrapolation)
Measured: Days 1-7
PK parameters - AUC (0-24)
AUC from time zero to 24 hours (AUC 0-24)
Measured: Days 1-7
PK parameters - Lambda-z
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for Lambda-z (Slope of the regression line passing through the apparent elimination phase in a concentration vs time plot)
Measured: Days 1-7
PK parameters - CL
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for CL (Clearance: the volume of plasma cleared per unit time)
Measured: Days 1-7
PK parameters - Vd
PK parameters will be calculated using the apparent volume of distribution following oral dosing
Measured: Days 1-7
PK parameters -T 1/2el
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for T1/2el (The elimination half-life)
Measured: Days 1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start20 Mar 2018
- Primary completion31 Dec 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Up to 5 cohorts of 8 subjects each will be enrolled. Subjects in each cohort will be randomized 6:2 to receive multiple oral doses of TP 271 at 1 of 5 ascending doses of TP-271 or placebo once or twice daily for 7 days, as shown in the table below. Every effort will be made to dose all subjects in a cohort on the same day. Proposed Oral Doses of Study Drug by Dose Cohort Cohort Dose Regimen Proposed Oral Dose A Once daily 50 mg TP-271 q24 (n = 6) or matching placebo (n = 2) B Once daily 100 mg TP-271 q24 (n = 6) or matching placebo (n = 2) C Once daily 200 mg TP-271 q24 (n = 6) or matching placebo (n = 2) D Once daily 300 mg TP-271 q24 (n = 6) or matching placebo (n = 2) E Once daily 400 mg TP-271 q24 (n = 6) or matching placebo (n = 2) Abbreviations: q24 = every 24 hours.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tetraphase Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Larry Tsai, MD, Study director, Tetraphase Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450187
- Sponsor's protocol ID
- TP-271-004
- Status last verified
- Dec 2021
- First submitted
- 16 Feb 2018
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral TP-271 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03450187
- Acronym / sponsor ID
- TP-271-004
- Conditions
- Bacterial Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tetraphase Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1, single-center, randomized, placebo-controlled, double-blind, multiple ascending-dose study to assess the safety, tolerability, and PK of oral TP-271 in healthy adult subjects. Male or female subjects aged 18 to 50 years who fulfill the inclusion/exclusion criteria will be enrolled in this study.
Detailed description
This is a phase 1, single-center, randomized, placebo-controlled, double-blind, multiple ascending-dose study to assess the safety, tolerability, and PK of oral TP-271 in healthy adult subjects. Male or female subjects aged 18 to 50 years who fulfill the inclusion/exclusion criteria will be enrolled in this study.
Up to 5 cohorts of 8 subjects each (up to a total of 40 subjects) will be enrolled. Subjects in each cohort will be randomized 6:2 to receive multiple oral doses of TP 271 or placebo. Every effort will be made to dose all subjects in a cohort on the same day.
Doses of study drug will be administered orally either once daily in the morning or twice daily in the morning and evening from Days 1 to 7. In all subjects, the morning dose will be administered following an overnight fast (minimum 8 hours) of food and all beverages, except for water. For subjects in Cohorts D and E only, the evening dose will be administered following a minimum 3-hour fast of food and all beverages, except for water. Fasting in all cohorts will continue for at least 2 hours following each study drug administration.
During the Screening Period (within 28 days prior to the subject receiving study drug), each subject will be assessed for eligibility. Each subject must sign and date an ICF prior to undergoing any study-related procedures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Up to 5 cohorts of 8 subjects each will be enrolled. Subjects in each cohort will be randomized 6:2 to receive multiple oral doses of TP 271 at 1 of 5 ascending doses of TP-271 or placebo once or twice daily for 7 days, as shown in the table below. Every effort will be made to dose all subjects in a cohort on the same day. Proposed Oral Doses of Study Drug by Dose Cohort Cohort Dose Regimen Proposed Oral Dose A Once daily 50 mg TP-271 q24 (n = 6) or matching placebo (n = 2) B Once daily 100 mg TP-271 q24 (n = 6) or matching placebo (n = 2) C Once daily 200 mg TP-271 q24 (n = 6) or matching placebo (n = 2) D Once daily 300 mg TP-271 q24 (n = 6) or matching placebo (n = 2) E Once daily 400 mg TP-271 q24 (n = 6) or matching placebo (n = 2) Abbreviations: q24 = every 24 hours.
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Active comparator | Drug: TP-27150 mg TP-271 q24 (n=6), a novel, broad-spectrum tetracycline-class antibiotic or matching placebo (n=2) once daily for 7 days. |
| Cohort B | Active comparator | Drug: TP-271100 mg TLP-271 q24 (n=6), a novel, broad spectrum tetracycline-class antibiotic or matching placebo (n=2) once daily for 7 days. |
| Cohort C | Active comparator | Drug: TP-271200 mg TP-271 q24 (n=6), a novel, broad spectrum tetracycline-class antibiotic or matching placebo (n=2) once daily for 7 days. |
| Cohort D | Active comparator | Drug: TP-271300 mg TP-271 q24 (n=6), a novel, broad spectrum tetracycline-class antibiotic or matching placebo (n=2) once daily for 7 days. |
| Cohort E | Active comparator | Drug: TP-271400 mg TP-271 q24 (n=6), a novel, broad spectrum tetracycline-class antibiotic or matching placebo (n=2) once daily for 7 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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 to 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 (HIV) types 1 and 2 and hepatitis B and C
- Have the ability to communicate with the study unit staff in a manner sufficient to carry out all protocol procedures as described
Key exclusion criteria (32 listed)
- 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, may either put the subject at risk due to 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 of the eligibility range specified in Appendix D are exclusionary; for clinical laboratory values that are not included in Appendix D, values outside of the reference range are exclusionary, except for those parameters listed in Table 4).
- Table 4 Acceptable Out-of-Range Clinical Laboratory Values
- Bicarbonate (a) Chloride GGT HDL cholesterol LDH LDL cholesterol Phosphorus
- Chloride HDL cholesterol LDL cholesterol Phosphorus Triglycerides
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TP-271multiple oral doses of TP-271 or placebo, randomized 6:2, doses escalating 50 mg, 100 mg, 200 mg, 300 mg, 400 mg once daily for 7 days. | Drug | Cohort A, Cohort B, Cohort C, Cohort D, Cohort E |
Primary outcome
Adverse Events
Time frame: From the time of signing of the informed consent form throughout study completion (approximately 39 days)
Incidence, intensity, and type of adverse events.
A Directed Physical Examination including chest/respiratory
Time frame: Day -1 to the End of Study visit, Day 21
changes in physical examination findings for chest/respiratory
A Directed Physical Examination including heart/cardiovascular
Time frame: Day -1 to the End of study visit, Day 21
Changes in Physical Examination including heart/cardiovascular
Vital Signs including Pulse Rate
Time frame: Day -1 to the End of study visit, Day 21
Changes in Pulse Rate
Vital Signs including respiration rate
Time frame: Day -1 to the End of study visit, Day 21
Changes in respiration rate
Vital Signs including body temperature
Time frame: Day -1 to the end of study visit, Day 21
Changes in body temperature
Vital Signs including blood pressure
Time frame: Day -1 to the End of study visit, Day 21
Changes in blood pressure
ECG measurements including PR interval
Time frame: Day -1 to the End of study visit, Day 21
Changes in PR interval > or=20
ECG measurements including QRS interval
Time frame: Day -1 to the end of study visit, Day 21
Changes in QRS interval> or=10
ECG measurements including QTcF interval
Time frame: Day -1 to the end of study visit, Day 21
Changes in QTcF interval 30 to 60, > or =60
Safety Laboratory results including clinical chemistry
Time frame: Day -1 to the End of study visit, Day 21
Changes in safety laboratory results including clinical chemistry
Safety Laboratory results including electrolytes
Time frame: Day -1 to the End of study visit, Day 21
Changes in safety laboratory results including electrolytes
Safety Laboratory results including hematology
Time frame: Day -1 to the End of study visit, Day 21
Changes in safety laboratory results including hematology
Safety Laboratory results including blood glucose
Time frame: Day -1 to the End of study visit, Day 21
Changes in Safety laboratory results including glucose
Safety Laboratory results including coagulation
Time frame: Day -1 to the End of study visit, Day 21
Changes in Safety Laboratory results including coagulation
12 secondary outcomes
Plasma concentrations
Time frame: Days 1-7
Urine pharmacokinetics
Time frame: Days 1-7
PK parameters - Cmax
Time frame: Days 1-7
PK parameters- Tmax
Time frame: Days 1-7
PK parameters AUC (0-last)
Time frame: Days 1-7
PK parameters - AUC (0-inf)
Time frame: Days 1-7
PK parameters- AUC% extrapolated
Time frame: Days 1-7
PK parameters - AUC (0-24)
Time frame: Days 1-7
PK parameters - Lambda-z
Time frame: Days 1-7
PK parameters - CL
Time frame: Days 1-7
PK parameters - Vd
Time frame: Days 1-7
PK parameters -T 1/2el
Time frame: Days 1-7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larry Tsai, MD study director
Tetraphase Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TP-271 in people with Bacterial Infections, run by Tetraphase Pharmaceuticals, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: From the time of signing of the informed consent form throughout study completion (approximately 39 days)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.