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Healthy SubjectsPhase 1BALNCT03691584

Phase 1, Safety and Bronchopulmonary PK Study in Healthy Volunteers

A Phase 1 study testing TP-6076 and Bronchoalveolar lavage in people with Healthy Subjects, run by Tetraphase Pharmaceuticals, Inc at 1 site in United Kingdom.

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, PK and safety study in a maximum of 25 healthy subjects who have provided a bronchoalveolar lavage (BAL) sample. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
TP-6076 and Bronchoalveolar lavage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited Kingdom
Study dates
26 Nov 2018to 18 Dec 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

  • The following inclusion criteria must be met for a subject to be eligible for inclusion in the study:
  • Status : Healthy subject
  • Gender : Male or female
  • Age : 18 to 50 years, inclusive, at screening
  • Body mass index (BMI) : 18.0 to 30.0 kg/m2, inclusive, at screening
  • Weight : 50 to 105 kg, inclusive, at screening
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  • At screening, females must be non-pregnant and non-lactating, or of non childbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1 year post menopausal [amenorrhoea duration of 12 consecutive months]); non-pregnancy will be confirmed for all females by a serum pregnancy test conducted at screening, admission to the CPU, and follow up.
  • Post-menopausal females using hormone replacement therapy should be on a stable regimen and be using this since at least 3 months prior to the first study drug administration.
  • Female subjects of childbearing potential who have a fertile male sexual partner must agree to use adequate contraception from screening until 90 days after the follow up visit. Adequate contraception will be methods with low user dependency (ie, implanted hormonal contraception, an intrauterine device, an intrauterine hormone releasing system, bilateral tubal occlusion, and/or a sole vasectomised male partner with medical assessment). Also, total abstinence, in accordance with the lifestyle of the subject, is acceptable.
  • Male subjects, if not surgically sterilized, must agree to use adequate contraception when engaging in sexual activity with a female of childbearing potential and not to donate sperm from admission to the CPU until 90 days after the follow-up visit. Adequate contraception for the male subject (and his female partner) will be methods with low user dependency (ie, implanted hormonal contraception, an intrauterine device, an intrauterine hormone releasing system, bilateral tubal occlusion, and/or a sole vasectomised male subject with medical assessment). Also, total abstinence, in accordance with the lifestyle of the subject, is acceptable.
  • All prescribed medication must have been stopped at least 30 days prior to admission to the CPU. An exception is made for hormonal contraceptives and a stable regimen of hormone replacement therapy, which may be used throughout the study.
  • All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's Wort) must have been stopped at least 14 days prior to admission to the CPU. An exception is made for paracetamol, which is allowed up to admission to the CPU.
  • Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks), and grapefruit (juice) from 48 hours prior to admission to the CPU.
  • Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.
  • Willing to comply with the study procedures.
  • Willing and able to sign the ICF.

Who cannot join

  • A subject who meets any of the following exclusion criteria will not be eligible for inclusion in the study:
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  • Previous participation in the current study.
  • Employee of PRA Health Sciences (PRA), Hammersmith Medicines Research Ltd. (HMR), or Tetraphase Pharmaceuticals, Inc.
  • Subjects who may not tolerate a BAL, or cannot undergo a BAL due to the presence of contraindications to a BAL (including abnormal blood coagulation parameters, refractory hypoxemia, reactive airway disease or asthma, unstable angina or acute myocardial infarction in the 6 months prior to the first study drug administration).
  • History of any relevant lung disease.
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  • History of relevant drug (including tetracycline-class antibiotics) and/or food allergies.
  • Using tobacco products or electronic cigarettes within 6 months prior to the first study drug administration.
  • History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 2 years prior to the first study drug administration.
  • Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, cotinine, and alcohol) at screening and admission to the CPU.
  • Average intake of more than 24 units of alcohol per week: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
  • Positive screen for hepatitis B surface antigen (HBsAg), antihepatitis C virus (HCV) antibodies, or antihuman immunodeficiency virus (HIV) 1 and 2 antibodies.
  • Participation in a drug study within 60 days prior to the first study drug administration in the current study. Participation in more than 3 other drug studies in the 10 months prior to the first study drug administration in the current study.
  • Donation or loss of more than 400 mL of blood within 90 days prior to the first study drug administration. Donation or loss of more than 1.5 liters of blood (for male subjects)/more than 1.0 liters of blood (for female subjects) in the 10 months prior to the first study drug administration in the current study.
  • Significant and/or acute illness within 5 days prior to the first study drug administration that may impact safety assessments, in the opinion of the Investigator.
  • Unsuitable veins for infusion or blood sampling.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Hammersmith Medicines Research

    London

Other trials in United Kingdom

About this study

Official title: A Phase 1, Open-label, Randomized, PK and Safety Study To Assess Bronchopulmonary Disposition of Intravenous TP-6076 in Healthy Men and Women

This is a Phase 1, open-label, randomized, PK and safety study in a maximum of 25 healthy subjects who have provided a bronchoalveolar lavage (BAL) sample.

Read the detailed description

This is a Phase 1, open-label, randomized, PK and safety study in a maximum of 25 healthy subjects who have provided a bronchoalveolar lavage (BAL) sample. The dose planned to be administered in this study is an iv infusion of 30 mg TP 6076 q24h for 4 consecutive days (starting on Day 1 and ending on Day 4).

Subjects will be randomized to undergo a BAL at a single time point: either 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4. The BAL will be conducted in 5 different subjects at each of the 4 time points, adding up to a total of 20 subjects.

Being tested
TP-6076, Bronchoalveolar lavage

What participants receive

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

  • TP-6076Drug

    The dose planned to be administered in this study is an iv infusion of 30 mg TP 6076 q24h for 4 consecutive days (starting on Day 1 and ending on Day 4).

  • Bronchoalveolar lavageProcedure or surgery

    Also called BAL

    Subjects will be randomized to undergo a BAL at a single time point: either 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4.

Study groups in NCT03691584
Study groupRoleWhat they receive
BAL PK studyExperimentalBronchoalveolar lavage procedure performed at either 2, 4, 8, or 24 hours after final dose of TP-6076 on Day 4
Receives: Drug: TP-6076; Procedure: Bronchoalveolar lavage

What is being measured

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

  1. Concentrations of TP-6076 in plasma

    Pharmacokinetics

    Measured: Up to 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4.

  2. Concentrations of TP-6076 in epithelial lining fluid (ELF)

    Measured: Up to 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4.

  3. Concentrations of TP-6076 in alveolar macrophages (AMs)

    Measured: Up to 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4.

  4. maximum observed concentration (Cmax)

    Measured: Up to 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4.

  5. time to maximum observed concentration (Tmax)

    Measured: Up to 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4.

Secondary outcomes (1)

  1. collection of adverse events

    Measured: Screening through Day 20 (+/- 5 days)

Timeline

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

  1. First posted2 Oct 2018
  2. Study start26 Nov 2018
  3. Primary completion30 Jun 2019
  4. Study completion18 Dec 2019

Resources

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
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03691584
Sponsor's protocol ID
TP-6076-003
Acronym
BAL
Status last verified
Dec 2021
First submitted
27 Sep 2018
Last updated
17 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TP-6076 and Bronchoalveolar lavage in people with Healthy Subjects, run by Tetraphase Pharmaceuticals, Inc at 1 site in United Kingdom.

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 16 inclusion and 16 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 Kingdom. 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?

Concentrations of TP-6076 in plasma (time frame: Up to 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4.). 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?

On the ClinicalTrials.gov record for NCT03691584.

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.

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