Normal Drug TolerancePhase 1BALNCT01989949

Safety and Pharmacokinetic (PK) Study to Assess Bronchopulmonary Disposition of IV Eravacycline (TP-434) in Healthy Men and Women

A Phase 1 study testing TP-434 (Eravacycline) reconstituted and administered via an IV infusion in people with Normal Drug Tolerance, run by Tetraphase Pharmaceuticals, Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a phase 1, open-label, randomized pharmacokinetic and safety study in healthy adult subjects, who will undergo bronchoscopy and bronchoalveolar lavage (BAL) after receiving seven (7) doses of 1.0 mg/kg IV TP-434. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Normal Drug Tolerance
What is being tested?: TP-434 (Eravacycline) reconstituted and administered via an IV infusion
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Nov 2012to Apr 2013
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy males or non-pregnant, non-lactating healthy females
Age >18 to ≤ 65 years of age, inclusive
Body mass index of 18 to 33 kg/m2 or, if outside the range, considered not clinically significant by the Investigator
Must be willing and able to communicate and participate in the whole study
Must provide written informed consent
Must agree to use adequate methods of contraception

Who cannot join

Participation in a clinical research study within the previous 3 months
Subjects who have previously received TP-434
History of any drug or alcohol abuse in the past 2 years
Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
Current smokers and those who have smoked within the last 6 months.
Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the Investigator at screening

Show all 14Show fewer

Clinically significant abnormal biochemistry, haematology, coagulation or urinalysis as judged by the Investigator
Positive tests for drugs of abuse
Positive hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV; I and II) results
History of chronic respiratory disorders as judged by the Investigator
Serious adverse reaction or serious hypersensitivity to tetracyclines, midazolam or like compound, lidocaine or like compounds, or the formulation excipients
Donation or loss of greater than 400 mL of blood within the previous 3 months
Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (with the exception of anti inflammatory, anti-hypertensive medications, or hormone replacement therapy) in the 14 days before Investigational Medicinal Product administration unless judged to not interfere with the study objectives according to the Investigator and sponsor's medical monitor
Failure to satisfy the Investigator of fitness to participate for any other reason

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for Anti-infective Research and Development; Hartford Hospital
Hartford, Connecticut, 06102

Other trials in United States

About this study

Official title: Phase 1, Open-Label, Safety and Pharmacokinetic Study to Assess Bronchopulmonary Disposition of Intravenous TP-434 in Healthy Men and Women

Read the detailed description

Approximately 20 subjects will be enrolled into the study at one (1) investigational site. The population for this study is healthy male and female subjects 18 to 65 years of age.

This study includes a Screening Period of up to 30 days, a 4 day, open-label Treatment Period, and a two week Follow-up Period. There will be one 6 day/5 night inpatient stay (Days -1 to 5) during the Treatment Period and one outpatient visit at the end of the Follow-up Period. Excluding the Screening Period, the total duration of confinement (in the Clinical Research Center) will be approximately six (6) days and the total study duration, not including screening, will be approximately three (3) weeks.

Participants will be admitted to the Clinical Research Center on Day -1. Participants will receive four (4) days of intravenous TP-434 1.0 mg/kg of body weight twice daily (q12h) for three consecutive days and a morning dose on day four (4) (for a total of 7 doses) starting on Day 1. Blood and urine samples, ECGs, and vital signs will be collected for safety analysis at specified time points.

Pharmacokinetic blood sampling will occur on Day 4before and after the Day 4 dose of TP-434 at specified time points.

Participants will be randomized to a single BAL procedure time point. Bronchoscopy and BAL will be performed at the following time points after dosing of TP-434 on Day 4: two (2), four (4), six (6), and 12 hours after start of infusion. Bronchoscopy and BAL will be conducted for up to five (5) different participants at each time point. Each subject will undergo bronchoscopy and BAL only once.

Conditions: Normal Drug Tolerance
Being tested: TP-434 (Eravacycline) reconstituted and administered via an IV infusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TP-434 (Eravacycline) reconstituted and administered via an IV infusionDrug

Study groups in NCT01989949
Study group	Role	What they receive
TP-434 (Eravacycline) via IV infusion	Experimental	TP-434 (Eravacycline) reconstituted and administered via IV infusion at a dose of 1 mg/kg, every 12 hours, for 7 doses over 4 days. Receives: Drug: TP-434 (Eravacycline) reconstituted and administered via an IV infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

To determine the steady-state plasma pharmacokinetics and disposition of TP-434 into the epithelial lining fluid (ELF) and alveolar macrophages (AM) of healthy adult subjects after intravenous (IV) administration.
Measured: End of Therapy (Day 4)

Secondary outcomes (1)

To determine the safety and tolerability of TP-434 in healthy adult subjects based primarily on the incidence, intensity and type of adverse events (AEs), clinical laboratory assessments, physical examinations, vital signs, and 12-lead ECGs.
Measured: Screening Visit through Day 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Apr 2013

First posted21 Nov 2013 (estimated)
Study startNov 2012
Primary completionJan 2013
Study completionApr 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Normal Drug ToleranceStudies 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: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01989949
Sponsor's protocol ID: TP-434-006
Acronym: BAL
Status last verified: Dec 2021
First submitted: 10 Sep 2013
Last updated: 17 Dec 2021
Results posted: No
Data monitoring committee: No

Publications

Ji X-w, Mak WY, Xue F, Yang W-y, Kuan IH-S, Xiang X-q, Li Y, Zhu X. Population pharmacokinetics and pulmonary modeling of eravacycline and the determination of microbiological breakpoint and cutoff of PK/PD. Antimicrob Agents Chemother. 2025 Mar 5;69(3):e0106524. doi: 10.1128/aac.01065-24. Epub 2025 Jan 29.
PubMed 39878492

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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: Phase 1, Open-Label, Safety and Pharmacokinetic Study to Assess Bronchopulmonary Disposition of Intravenous TP-434 in Healthy Men and Women
ClinicalTrials.gov ID: NCT01989949
Acronym / sponsor ID: BAL / TP-434-006
Conditions: Normal Drug Tolerance
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Tetraphase Pharmaceuticals, IncIndustry (pharma, biotech, devices)
Collaborators: Department of Health and Human Services
Study start: Nov 2012
Primary completion: Jan 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 21 Nov 2013 (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.

Detailed description

Approximately 20 subjects will be enrolled into the study at one (1) investigational site. The population for this study is healthy male and female subjects 18 to 65 years of age.

Pharmacokinetic blood sampling will occur on Day 4before and after the Day 4 dose of TP-434 at specified time points.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TP-434 (Eravacycline) via IV infusion	Experimental	Drug: TP-434 (Eravacycline) reconstituted and administered via an IV infusionTP-434 (Eravacycline) reconstituted and administered via IV infusion at a dose of 1 mg/kg, every 12 hours, for 7 doses over 4 days.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Healthy males or non-pregnant, non-lactating healthy females
Age >18 to ≤ 65 years of age, inclusive
Body mass index of 18 to 33 kg/m2 or, if outside the range, considered not clinically significant by the Investigator
Must be willing and able to communicate and participate in the whole study
Must provide written informed consent

Key exclusion criteria (14 listed)

Participation in a clinical research study within the previous 3 months
Subjects who have previously received TP-434
History of any drug or alcohol abuse in the past 2 years
Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
Current smokers and those who have smoked within the last 6 months.

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-434 (Eravacycline) reconstituted and administered via an IV infusion	Drug	TP-434 (Eravacycline) via IV infusion

Primary outcome

To determine the steady-state plasma pharmacokinetics and disposition of TP-434 into the epithelial lining fluid (ELF) and alveolar macrophages (AM) of healthy adult subjects after intravenous (IV) administration.
Time frame: End of Therapy (Day 4)

1 secondary outcome

To determine the safety and tolerability of TP-434 in healthy adult subjects based primarily on the incidence, intensity and type of adverse events (AEs), clinical laboratory assessments, physical examinations, vital signs, and 12-lead ECGs.
Time frame: Screening Visit through Day 20

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.
Derived from this study: PubMed 39878492Ji X-w, Mak WY, Xue F, Yang W-y, Kuan IH-S, Xiang X-q, Li Y, Zhu X. Population pharmacokinetics and pulmonary modeling of eravacycline and the determination of microbiological breakpoint and cutoff of PK/PD. Antimicrob Agents Chemother. 2025 Mar 5;69(3):e0106524. doi: 10.1128/aac.01065-24. Epub 2025 Jan 29.

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The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study
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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.

Patrick T Horn, MD, PhD study director

Tetraphase Pharmaceuticals, Inc

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 14 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?

To determine the steady-state plasma pharmacokinetics and disposition of TP-434 into the epithelial lining fluid (ELF) and alveolar macrophages (AM) of healthy adult subjects after intravenous (IV) administration. (time frame: End of Therapy (Day 4)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01989949, which also lists 1 linked publication.

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.