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Healthy VolunteersPhase 1NCT02774902

TAK-438_110 Drug Interaction With Cytochrome P450 3A4 (CYP3A4) Inhibitor Clarithromycin

A Phase 1 study testing TAK-438 and Clarithromycin in people with Healthy Volunteers, run by Takeda.

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

The purpose of this study is to evaluate the effect of multiple oral doses of clarithromycin on the pharmacokinetics of TAK-438 and its metabolites in healthy male adult participants following a single oral dose of TAK-438. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
TAK-438 and Clarithromycin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
No sites listed yet
Study dates
Aug 2010to Sep 2010
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 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • In the opinion of the investigator the participant is capable of understanding and complying with protocol requirements.
  • The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
  • Is a healthy adult male participant, of non-Japanese origin.
  • Is aged 18 to 45 years, inclusive, at the time of informed consent and first study medication dose.
  • Weighs at least 45 kg and has a body mass index (BMI) between 18 and 30 kg/m^2, inclusive at Screening.
  • A male participant who is sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
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  • Has clinical laboratory evaluations (including clinical chemistry, hematology, and urinalysis), within the reference range for the testing laboratory. Participants with evaluations outside the reference range that are deemed not clinically significant by the investigator may be included at investigator discretion unless these are specifically identified in the exclusion criteria.
  • Is willing to abstain from caffeine and alcohol from 72 hours before first dose (Day 1) until the Follow-up call.
  • Is willing to abstain from strenuous exercise from 72 hours before first dose (Day 1) until the Follow-up call.
  • Is willing to provide a sample for pharmacogenomic analysis.

Who cannot join

  • Has received any investigational compound within 90 days prior to the first dose on Day 1.
  • Has received TAK-438 in a previous clinical study or as a therapeutic agent.
  • Is an immediate family member, study site employee, or in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
  • Has a known hypersensitivity or allergies to clarithromycin or any associated excipients.
  • Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 5 years prior to the Screening Visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
  • Has taken or is required to take any excluded medication.
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  • Intends to donate sperm during the course of this study or for 12 weeks thereafter.
  • Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking TAK-438, or a similar drug in the same class, or clarithromycin, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias.
  • Has a history or clinical manifestations of significant symptomatic, gastroesophageal reflux disease (GERD), erosive esophagitis (EE), duodenal ulcer, gastric ulcer, dyspepsia, Barrett esophagus (BE), or Zollinger-Ellison syndrome.
  • Has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, esophageal reflux, peptic ulcer disease, EE frequent [more than once per week], occurrence of heartburn, or any surgical intervention [eg, cholecystectomy]).
  • Has a history of cancer, except basal cell carcinoma that has been in remission for at least 5 years prior to Day 1.
  • Has a positive test result for hepatitis A, hepatitis B surface antigen, antibody to hepatitis C virus, or human immunodeficiency virus at Screening.
  • Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 6 weeks prior to Check-in Day -1. Urine test is positive at Screening or Check-in (Day -1).
  • Has a positive alcohol breath test at the Screening or Check-in (Day -1).
  • Has confirmed positive result for drugs of abuse at the Screening Visit or Check-in (Day -1).
  • Has abnormal Screening or Day -1 laboratory values that suggest a clinically significant underlying disease or participant with the following laboratory abnormalities: has an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level which exceeds 3*upper limit of normal (ULN) set by the testing laboratory at the Screening Visit or Check-in (Day -1).
  • Has poor peripheral venous access.
  • Has donated or lost 450 mL or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 90 days prior to Day 1.
  • Is unable to understand verbal or written English or any other language for which a certified translation of the informed consent and other material supplied for completion by participant is available.
  • Has a Screening or Check-in (Day -1) abnormal (clinically significant) electrocardiogram (ECG). Entry of any participant with an abnormal (not clinically significant) ECG must be approved, and documented by signature by the principal investigator.
  • Has a marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval >450 ms) on ECG at the Screening Visit.
  • Has a history of clinically significant inflammatory disease or allergy (eg, hay fever [hay fever sufferers who do not require medication may be permitted], asthma, eczema), autoimmune disease (eg, psoriasis, lupus), or history of chronic respiratory disease (eg, emphysema or chronic obstructive pulmonary disease).
  • Has a history of additional risk factors for torsades de pointes (eg, heart failure, hypokalemia, family history of Long QT Syndrome).
  • Is considered by the investigator, for any reason, to be an unsuitable candidate for participating in this study.

About this study

Official title: A Phase 1, Open-Label, Sequential Design Study to Evaluate the Effect of Multiple Oral Doses of Clarithromycin on the Pharmacokinetics of a Single Oral Dose of TAK-438

The purpose of this study is to evaluate the effect of multiple oral doses of clarithromycin on the pharmacokinetics of TAK-438 and its metabolites in healthy male adult participants following a single oral dose of TAK-438.

Read the detailed description

The drug being tested in this study is called TAK-438. TAK 438 is being tested to assess the effect of multiple oral doses of clarithromycin on the pharmacokinetics of TAK-438.

The study will enroll approximately 16 healthy adult male participants of non-Japanese origin. Participants will be assigned:

  • TAK-438 40 mg
  • Clarithromycin 500 mg

All participants will be asked to take 2 tablet of TAK-438 20 mg orally, once on Days 1 and 8 along with Clarithromycin 500 mg, tablets, orally twice daily from Days 3 to 9.

This single center trial will be conducted in Europe. The overall time to participate in this study is maximum of 44 days. Participants will be confined to site for 10 days, and a final visit after 4 days after discharge from the unit for a follow-up assessment.

Being tested
TAK-438, Clarithromycin
Keywords
Drug Therapy

What participants receive

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

Study groups in NCT02774902
Study groupRoleWhat they receive
TAK-438 40 mg + Clarithromycin 500 mgExperimentalTAK-438 40 mg, tablets, orally once on Days 1 and 8 along with clarithromycin 500 mg, tablets, orally twice daily from Days 3 to 9.
Receives: Drug: TAK-438; Drug: Clarithromycin

What is being measured

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

  1. Cmax: Maximum Observed Plasma Concentration for TAK-438 and TAK-438 Metabolites (M-I, M-II, M-III, M-IV-Sul)

    Measured: Days 1 and 8 pre-dose and at multiple timepoints (up to 48 hours) post-dose

  2. AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-438 and TAK-438 Metabolites (M-I, M-II, M-III, M-IV-Sul)

    Measured: Days 1 and 8 pre-dose and at multiple timepoints (up to 48 hours) post-dose

  3. AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-438 and TAK-438 Metabolites (M-I, M-II, M-III, M-IV-Sul)

    Measured: Days 1 and 8 pre-dose and at multiple timepoints (up to 48 hours) post-dose

  4. AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-438 and TAK-438 Metabolites (M-I, M-II, M-III, M-IV-Sul)

    Measured: Days 1 and 8 pre-dose and at multiple timepoints (up to 48 hours) post-dose

Secondary outcomes (10)

  1. Ratio of TAK-438 Metabolites Cmax to TAK-438 Cmax

    Measured: Days 1 and 8 pre-dose and at multiple timepoints (up to 48 hours) post-dose

  2. Ratio of TAK-438 Metabolites AUClast to TAK-438 AUClast

    Measured: Days 1 and 8 pre-dose and at multiple timepoints (up to 48 hours) post-dose

  3. Ratio of TAK-438 Metabolites AUC∞ to TAK-438 AUC∞

    Measured: Days 1 and 8 pre-dose and at multiple timepoints (up to 48 hours) post-dose

  4. Ratio of TAK-438 Metabolites AUC(0-24) to TAK-438 AUC(0-24)

    Measured: Days 1 and 8 pre-dose and at multiple timepoints (up to 48 hours) post-dose

  5. Predose Observed Plasma Concentration of Clarithromycin

    Measured: Days 3 to 9 pre-dose (-1 hours [1 hour before TAK-438 dosing]) and (11 hours [11 hours after TAK 438 dosing])

  6. Percentage of Participants who Experience at Least One Treatment Emergent Adverse Event (TEAE)

    Measured: Day 1 until Day 14 or early termination

  7. Percentage of Participants With Markedly Abnormal Laboratory Values

    Measured: Screening (Days -28 to -2) up to Day 10

  8. Percentage of Participants With Markedly Abnormal Vital Sign Measurements at Least Once Post-dose

    Measured: Screening (Days -28 to -2) up to Day 10

  9. Percentage of Participants With Markedly Abnormal Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose

    Measured: Screening (Days -28 to -2) up to Day 10

  10. Percentage of Participants With Clinical Significant Change in Physical Examination

    Measured: Screening (Days -28 to -2) up to Day 10

Timeline

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

  1. First posted17 May 2016 (estimated)
  2. Study startAug 2010
  3. Primary completionSep 2010
  4. Study completionSep 2010

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02774902
Sponsor's protocol ID
TAK-438-110
Other IDs
2010-020813-10, U1111-1181-8324
Status last verified
May 2016
First submitted
13 May 2016
Last updated
17 May 2016
Results posted
No
Data monitoring committee
No

Publications

  • Jenkins H, Jenkins R, Patat A. Effect of Multiple Oral Doses of the Potent CYP3A4 Inhibitor Clarithromycin on the Pharmacokinetics of a Single Oral Dose of Vonoprazan: A Phase I, Open-Label, Sequential Design Study. Clin Drug Investig. 2017 Mar;37(3):311-316. doi: 10.1007/s40261-016-0488-6.

    PubMed 27928738

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAK-438 and Clarithromycin in people with Healthy Volunteers, run by Takeda.

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 10 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 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Cmax: Maximum Observed Plasma Concentration for TAK-438 and TAK-438 Metabolites (M-I, M-II, M-III, M-IV-Sul) (time frame: Days 1 and 8 pre-dose and at multiple timepoints (up to 48 hours) post-dose). The study lists 4 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 NCT02774902, 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 May 2016.

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