Bacterial InfectionsPhase 1NCT03024034
A Phase 1 TP-271 Oral PK Single 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
The purpose of this study is to determine the safety and tolerability of up to 6 different single ascending oral doses of TP-271, ranging from 25 mg to 300 mg, in healthy adult male or female subjects. 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
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2017to 4 Jun 2018
- 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 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
- Female subjects must be of non-child bearing potential, either 1-year post menopausal or surgically sterile (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 through 90 days post-dosing 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 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 are exclusionary; for laboratory values that are not included in Appendix D, values outside of the reference range are exclusionary with the following exceptions (Table 3):
- Table 3 Acceptable Out-of-Range Clinical Laboratory Values Low Chemistry Values High Chemistry Values Out-of-Range Urinalysis Values Out of Range Hematology Values Bicarbonate Chloride High or low specific gravity High hematocrit Chloride HDL cholesterol Cloudy Basophils GGT LDL cholesterol Mucus Monocytes HDL cholesterol Phosphorus Crystals MCV LDH Triglycerides Ketones MCHC LDL cholesterol Hyaline casts MCH Phosphorus High or low pH RBC Triglycerides Urobilinogen a Bicarbonate >18 mEq/L. b Ketonuria is 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, EDTA, or any of the excipients in TP 271
- Clinically significant abnormality on a 12-lead ECG including the following:
- Rhythm other than sinus
Show all 24Show fewer
- 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 Investigator to be non pathologic
- History of seizures
- A history within 3 years of positive result on 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 study drug through the last study 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 treatment or within the previous 3 months (if the half-life of investigational agent is unknown) prior to receiving study drug on Day 1 or planned participation in another clinical study concurrent with the present trial
- History of difficulty donating blood or poor venous access
- Recent blood donation (1 unit or approximately 450 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 non-prescription 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 is permitted 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral TP-271 in Healthy Adult Subjects, Including 1 Cross-over Arm
The purpose of this study is to determine the safety and tolerability of up to 6 different single ascending oral doses of TP-271, ranging from 25 mg to 300 mg, in healthy adult male or female subjects.
Read the detailed description
This study is designed to assess oral TP-271, and the objectives of the study are to examine the safety, tolerability, and PK of oral TP-271 in healthy adult subjects after administration of a single dose. A single-dose, dose-escalating study design is common for early clinical studies. A cohort size of 8 subjects (6 receiving oral TP-271 and 2 receiving placebo) for the single ascending dose cohorts (Cohorts A through F) will allow sufficient data assessments of plasma and urine concentrations, plasma PK parameters, and safety without exposing large numbers of subjects to oral TP-271 in this clinical study. One additional cohort of 8 subjects will first receive treatment with TP-271 or TP-271 co-administered with ethylenediaminetetraacetic acid (EDTA) and then cross-over to treatment with the other study agent, which will allow a comparison of the bioavailability of TP-271 alone compared to TP-271 co-administered with EDTA, as well as allow additional assessment of plasma and urine concentrations, plasma PK parameters, and safety.
- 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
single oral dose of TP 271 or placebo, randomized 3:1, doses escalating as 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, and 300 mg, and a final crossover cohort of 50 mg TP-271 and 50 mg TP-271 with 250 mg of EDTA, or placebo and 250 mg of EDTA
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Active comparator | Oral dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 25 mg single dose (n = 6) or matching placebo (n = 2) Receives: Drug: TP-271 |
| Cohort B | Active comparator | Oral dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 50 mg single dose (n = 6) or matching placebo (n = 2) Receives: Drug: TP-271 |
| Cohort C | Active comparator | Oral dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 100 mg single dose (n = 6) or matching placebo (n = 2) Receives: Drug: TP-271 |
| Cohort D | Active comparator | Oral dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 150 mg single dose (n = 6) or matching placebo (n = 2) Receives: Drug: TP-271 |
| Cohort E | Active comparator | Oral dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 200 mg single dose (n = 6) or matching placebo (n = 2) Receives: Drug: TP-271 |
| Cohort F | Active comparator | Oral dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 300 mg single dose (n = 6) or matching placebo (n = 2) Receives: Drug: TP-271 |
| Cohort G | Active comparator | Oral dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 50 mg TP 271, cross-over to 50 mg TP 271/250 mg EDTA (n = 3); 50 mg TP 271/250 mg EDTA, cross-over to 50 mg TP 271 (n = 3); matching placebo, cross over to 250 mg EDTA (n= 1); or 250 mg EDTA, cross over to matching placebo (n = 1) Receives: Drug: TP-271 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE)
The incidence, intensity, and type of adverse events (AE) and the total number of participants experiencing AEs that are related to treatment
Outcome measures to be collected in support of the primary objective (safety and tolerability) include:
- The incidence, intensity, and type of AEs (from time of signing of informed consent form [ICF] through EOS);
- Changes in physical examination findings (Day -1 and EOS);
- Changes in vital signs (Day -1 through EOS);
- Changes in safety laboratory (chemistry, hematology, coagulation, urinalysis) results (Days -1 through EOS); and
- Changes in ECG measurements (Days -1 through EOS).
Measured: Through study completion, approximately 39 days
Physical Exams
Changes in physical examination findings
Measured: Through study completion, approximately 39 days
Vital Signs
Changes in vital signs
Measured: Through study completion, approximately 39 days
Safety Laboratory
Changes in safety laboratory (chemistry, hematology, coagulation, urinalysis) results that are considered abnormal, clinically significant and related to treatment
Measured: Through study completion, approximately 39 days
ECG measurements
Abnormal ECG measurements that are abnormal, clinically significant and related to treatment
Measured: Through study completion, approximately 39 days
Secondary outcomes (15)
Plasma Pharmacokinetic (PK) Analysis
Plasma concentrations of TP-271 and its C-4 epimer TP-9555 for PK analysis
Measured: Days 1-5
Urine Pharmacokinetic (PK) Analysis
Urine concentrations of TP-271 and its C-4 epimer TP-9555
Measured: Days 1-5
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 1-5
PK parameters - Tmax
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for Tmax [The time from dosing at which Cmax is apparent]
Measured: Days 1-5
PK parameters - C8
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for C8 [The concentration at 8 hours post-dose]
Measured: Days 1-5
PK parameters - C12
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for C8 [The concentration at 8 hours post-dose]
Measured: Days 1-5
PK parameters - C24
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for C24 [The concentration at 24 hours post-dose]
Measured: Days 1-5
PK parameters - AUC(0-last)
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 1-5
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 1-5
PK parameters - AUC% extrapolated
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for AUC%extrapolated [The percentage of AUC(0-inf) accounted for by extrapolation]
Measured: Days 1-5
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 1-5
PK parameters - T1/2el
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for T1/2el [The elimination half-life]
Measured: Days 1-5
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 1-5
PK parameters - Vd
The PK parameters of the epimer/parent will be calculated for Cmax and AUC(0-inf).
Measured: Days 1-5
PK parameters - epimer/parent
The PK parameters of the epimer/parent will be calculated for Cmax and AUC(0-inf).
Measured: Days 1-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start2 Mar 2017
- Primary completion1 Dec 2017
- Study completion4 Jun 2018
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tetraphase Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024034
- Sponsor's protocol ID
- TP-271-003
- Other IDs
- 15-0061
- Status last verified
- Dec 2021
- First submitted
- 9 Jan 2017
- Last updated
- 13 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 13 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, Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral TP-271 in Healthy Adult Subjects, Including 1 Cross-over Arm
- ClinicalTrials.gov ID
- NCT03024034
- Acronym / sponsor ID
- TP-271-003
- Conditions
- Bacterial Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Tetraphase Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 4 Jun 2018 (actual)
- First posted
- 18 Jan 2017 (estimated)
- 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.
The purpose of this study is to determine the safety and tolerability of up to 6 different single ascending oral doses of TP-271, ranging from 25 mg to 300 mg, in healthy adult male or female subjects.
Detailed description
This study is designed to assess oral TP-271, and the objectives of the study are to examine the safety, tolerability, and PK of oral TP-271 in healthy adult subjects after administration of a single dose. A single-dose, dose-escalating study design is common for early clinical studies. A cohort size of 8 subjects (6 receiving oral TP-271 and 2 receiving placebo) for the single ascending dose cohorts (Cohorts A through F) will allow sufficient data assessments of plasma and urine concentrations, plasma PK parameters, and safety without exposing large numbers of subjects to oral TP-271 in this clinical study. One additional cohort of 8 subjects will first receive treatment with TP-271 or TP-271 co-administered with ethylenediaminetetraacetic acid (EDTA) and then cross-over to treatment with the other study agent, which will allow a comparison of the bioavailability of TP-271 alone compared to TP-271 co-administered with EDTA, as well as allow additional assessment of plasma and urine concentrations, plasma PK parameters, and safety.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Active comparator | Drug: TP-271Oral dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 25 mg single dose (n = 6) or matching placebo (n = 2) |
| Cohort B | Active comparator | Drug: TP-271Oral dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 50 mg single dose (n = 6) or matching placebo (n = 2) |
| Cohort C | Active comparator | Drug: TP-271Oral dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 100 mg single dose (n = 6) or matching placebo (n = 2) |
| Cohort D | Active comparator | Drug: TP-271Oral dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 150 mg single dose (n = 6) or matching placebo (n = 2) |
| Cohort E | Active comparator | Drug: TP-271Oral dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 200 mg single dose (n = 6) or matching placebo (n = 2) |
| Cohort F | Active comparator | Drug: TP-271Oral dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 300 mg single dose (n = 6) or matching placebo (n = 2) |
| Cohort G | Active comparator | Drug: TP-271Oral dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 50 mg TP 271, cross-over to 50 mg TP 271/250 mg EDTA (n = 3); 50 mg TP 271/250 mg EDTA, cross-over to 50 mg TP 271 (n = 3); matching placebo, cross over to 250 mg EDTA (n= 1); or 250 mg EDTA, cross over to matching placebo (n = 1) |
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 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
Key exclusion criteria (24 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 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 are exclusionary; for laboratory values that are not included in Appendix D, values outside of the reference range are exclusionary with the following exceptions (Table 3):
- Table 3 Acceptable Out-of-Range Clinical Laboratory Values Low Chemistry Values High Chemistry Values Out-of-Range Urinalysis Values Out of Range Hematology Values Bicarbonate Chloride High or low specific gravity High hematocrit Chloride HDL cholesterol Cloudy Basophils GGT LDL cholesterol Mucus Monocytes HDL cholesterol Phosphorus Crystals MCV LDH Triglycerides Ketones MCHC LDL cholesterol Hyaline casts MCH Phosphorus High or low pH RBC Triglycerides Urobilinogen a Bicarbonate >18 mEq/L. b Ketonuria is 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, EDTA, or any of the excipients in TP 271
- Clinically significant abnormality on a 12-lead ECG including the following:
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-271single oral dose of TP 271 or placebo, randomized 3:1, doses escalating as 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, and 300 mg, and a final crossover cohort of 50 mg TP-271 and 50 mg TP-271 with 250 mg of EDTA, or placebo and 250 mg of EDTA | Drug | Cohort A, Cohort B, Cohort C, Cohort D, Cohort E, Cohort F, Cohort G |
Primary outcome
Adverse Events (AE)
Time frame: Through study completion, approximately 39 days
The incidence, intensity, and type of adverse events (AE) and the total number of participants experiencing AEs that are related to treatment Outcome measures to be collected in support of the primary objective (safety and tolerability) include: * The incidence, intensity, and type of AEs (from time of signing of informed consent form [ICF] through EOS); * Changes in physical examination findings (Day -1 and EOS); * Changes in vital signs (Day -1 through EOS); * Changes in safety laboratory (chemistry, hematology, coagulation, urinalysis) results (Days -1 through EOS); and * Changes in ECG measurements (Days -1 through EOS).
Physical Exams
Time frame: Through study completion, approximately 39 days
Changes in physical examination findings
Vital Signs
Time frame: Through study completion, approximately 39 days
Changes in vital signs
Safety Laboratory
Time frame: Through study completion, approximately 39 days
Changes in safety laboratory (chemistry, hematology, coagulation, urinalysis) results that are considered abnormal, clinically significant and related to treatment
ECG measurements
Time frame: Through study completion, approximately 39 days
Abnormal ECG measurements that are abnormal, clinically significant and related to treatment
15 secondary outcomes
Plasma Pharmacokinetic (PK) Analysis
Time frame: Days 1-5
Urine Pharmacokinetic (PK) Analysis
Time frame: Days 1-5
PK parameters - Cmax
Time frame: Days 1-5
PK parameters - Tmax
Time frame: Days 1-5
PK parameters - C8
Time frame: Days 1-5
PK parameters - C12
Time frame: Days 1-5
PK parameters - C24
Time frame: Days 1-5
PK parameters - AUC(0-last)
Time frame: Days 1-5
PK parameters - AUC(0-inf)
Time frame: Days 1-5
PK parameters - AUC% extrapolated
Time frame: Days 1-5
PK parameters - Lambda-z
Time frame: Days 1-5
PK parameters - T1/2el
Time frame: Days 1-5
PK parameters - CL
Time frame: Days 1-5
PK parameters - Vd
Time frame: Days 1-5
PK parameters - epimer/parent
Time frame: Days 1-5
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 13 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.
The record lists no contact. Use the official record to reach the sponsor.
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 24 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 13 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 (AE) (time frame: Through study completion, approximately 39 days). The study lists 5 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 13 Dec 2021.