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Hepatic ImpairmentPhase 1NCT05976321

A Study of TAK-279 in Adults With or Without Liver Damage

A Phase 1 study testing TAK-279 in people with Hepatic Impairment and Healthy Volunteers, run by Takeda at 4 sites 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

The main aim of this study is to find out how the body processes 1 dose of TAK-279 (pharmacokinetics) in participants with liver problems compared to participants without liver problems. Other aims are to check for side effects from TAK-279 and to learn how well participants tolerate 1 dose of TAK-279. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hepatic Impairment, Healthy Volunteers
What is being tested?
TAK-279
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
4 sitesUnited States
Study dates
22 Sep 2023to 15 Apr 2024
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants with Hepatic Impairment:
  • The participants must fulfill the following inclusion criteria to be eligible for participation in the study (participants who do not qualify based on a reversible condition or mild intercurrent illness may be re-screened after the condition is resolved. Screening tests may be repeated if in the Investigator's opinion the test needs to be repeated):
  • Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.
  • Adult male or female participant aged ≥18 years, at screening.
  • Has a body weight greater than 50 kilograms (kg) and has a body mass index (BMI) ≥18.0 and ≤42.0 kilograms per meter square (kg/m^2), at screening.
  • Continuous non-smoker or moderate smoker (≤10 cigarettes/day or the equivalent [including electronic cigarettes]) before screening. Participant must agree to smoke no more than 5 cigarettes or equivalent/day (including electronic cigarettes) from the 7 days prior to TAK-279 dosing.
Show all 27Show fewer
  • Aside from HI, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, or screening clinical laboratory profiles, as deemed by the Investigator or designee, including:
  • Supine blood pressure (BP) is ≥90/40 millimeters of mercury (mmHg) and ≤150/95 mmHg, at screening.
  • Supine pulse rate (PR) is ≥40 beats per minute (bpm) and ≤99 bpm, at screening.
  • Estimated creatinine clearance (CrCl) ≥60 millilitres per minute (mL/min) (using Cockcroft-Gault formula) at screening. Both estimated CrCl and estimated glomerular filtration rate (eGFR) using modification of diet in renal disease (MDRD) formula will be reported.
  • Have had chronic HI for at least 3 months before screening, and the HI must be stable, i.e., no significant changes in hepatic function in the 30 days preceding screening (or since the last visit if within 3 months before screening).
  • Has a score on the Child-Pugh Class at screening as follows:
  • Severe HI cohort, Child-Pugh Class C: ≥10 and ≤15.
  • Moderate HI cohort, Child-Pugh Class B: ≥7 and ≤9.
  • Mild HI cohort, Child-Pugh Class A: ≥5 and ≤6.
  • Female participants of childbearing potential agree to comply with any acceptable contraceptive requirements of the protocol.
  • Healthy Participants:
  • Understands the study procedures in the ICF and be willing and able to comply with the protocol.
  • Adult male or female participant aged ≥18 years, at screening. Participant will be matched to a participant with HI by age (±10 years) and sex.
  • Has a body weight greater than 50 kg and has a BMI ≥18.0 and ≤42.0 kg/m^2, at screening. Participant will be matched a participant with HI by body weight (±15 kg).
  • Continuous non-smoker or moderate smoker (≤10 cigarettes/day or the equivalent [including electronic cigarettes]) before screening. Participant must agree to smoke no more than 5 cigarettes or equivalent/day (including electronic cigarettes) from the 7 days prior to TAK-279 dosing.
  • Medically healthy with no clinically significant medical history, physical examination, vital signs, or screening clinical laboratory profiles, as deemed by the Investigator or designee, including:
  • Supine BP is ≥90/40 mmHg and ≤150/95 mmHg, at screening.
  • Supine PR is ≥40 bpm and ≤99 bpm, at screening.
  • Liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and total bilirubin (TBILI) within the upper limit of normal (ULN) at screening and at check-in.
  • Estimated CrCl ≥60 mL/min (using Cockcroft-Gault formula) at screening. Both estimated CrCl and eGFR using MDRD formula will be reported.
  • Female participants of childbearing potential agree to comply with any acceptable contraceptive requirements of the protocol.

Who cannot join

  • Participants with Hepatic Impairment:
  • The participant must be excluded from participating in the study if the participant:
  • Is mentally or legally incapacitated or has significant emotional problems at the time of screening or expected during the conduct of the study.
  • Has history or presence of clinically significant medical or psychiatric condition or disease (aside from HI) in the opinion of the Investigator or designee.
  • Has history of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
  • Has a history of any of the following:
Show all 81Show fewer
  • Active infection or febrile illness within 7 days prior to dosing, as assessed by the Investigator or designee.
  • Symptoms suggestive of systemic or invasive infection requiring hospitalization or treatment within 8 weeks prior to dosing.
  • Chronic or recurrent bacterial disease, including but not limited to chronic pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or chronic skin ulcerations/infections or fungal infections (except superficial nailbed mycosis).
  • An infected joint prosthesis unless that prosthesis has been removed or replaced within 60 days prior to dosing.
  • Opportunistic infections (e.g., Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).
  • Cancer or lymphoproliferative disease within 5 years prior to dosing, with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix is not exclusionary.
  • Known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy.
  • Liver or other solid organ transplant.
  • Has history or presence of alcoholism and/or drug abuse within the past 6 months prior to dosing, as determined by the Investigator or designee.
  • Has history or presence of clinically significant hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
  • Female with a positive pregnancy test or who is lactating.
  • Has electrocardiogram (ECG) abnormalities that are considered clinically significant and would pose an unacceptable risk to the participant if he or she participated in the study, in the opinion of the Investigator or designee.
  • Has positive results for the urine or saliva drug screen at screening or check-in, unless the positive drug screen is due to prescription drug use that is approved by the Investigator or designee and Sponsor.
  • Has positive results for urine or breath alcohol screen at screening or check-in.
  • Unable to refrain from or anticipates the use of any medication or substance (including prescription or over-the-counter, vitamin supplements, natural or herbal supplements).
  • Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to dosing and throughout the study.
  • Has made a donation of blood or had significant blood loss within 56 days prior to dosing.
  • Has made a plasma donation within 7 days prior to dosing.
  • Participated in another clinical study within 30 days prior to dosing. The 30-day window will be derived from the date of the last dosing in the previous study to Day 1 of the current study.
  • Herpes infections:
  • Participant has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 (demonstrated on physical examination and/or medical history) at screening or Day 1.
  • Participant has history of serious herpetic infection that includes any episode of disseminated disease, multidermatomal herpes simplex virus, herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (defined as 2 episodes within 2 years).
  • Positive results for non-herpetic viral diseases at screening:
  • Hepatitis C virus (HCV) antibody and a positive confirmatory test result for HCV Ribonucleic acid (RNA) (nucleic acid test or Polymerase chain reaction [PCR]).
  • Hepatitis B surface antigen (HBsAg)+, hepatitis B virus Deoxyribonucleic acid (DNA), or Hepatitis B core antibody (HBcAb)+ with positive hepatitis B virus DNA.
  • Human immunodeficiency virus (HIV).
  • Tuberculosis (TB):
  • Has history of active TB infection, regardless of treatment status.
  • Has signs or symptoms of active TB (including but not limited to chronic fever, chronic productive cough, night sweats, or weight loss) as judged by the Investigator or designee.
  • Has evidence of latent tuberculosis infection (LTBI) as evidenced by a positive QuantiFERON-TB Gold (QFT) result OR 2 indeterminant QFT results and does not have documentation of appropriate LTBI prophylaxis. Participant remains eligible if he or she can provide documentation of prior and complete treatment for LTBI (appropriate in duration and type per current local country guidelines).
  • Has had any imaging study during or 6 months prior to screening, including x-ray, chest computed tomography, magnetic resonance imaging, or other chest imaging suggesting evidence of current active or a history of active TB.
  • The participant has any of the following:
  • A history of esophageal or gastric variceal bleeding within the past 6 months and for which varices have not been adequately treated with medication and/or surgical procedure(s), or a history of bleeding due to gastric ulcers within the past 6 months, or presence of medium or large varices or varices with red wale signs based on a previous esophagogastroduodenoscopy (EGD) within 6 months before screening that have not been treated, if EGD performed within the past 6 months prior to screening is available.
  • The participant has grade >2 hepatic encephalopathy assessed using the West Haven criteria.
  • The participant has evidence of hepatopulmonary syndrome or portal-pulmonary hypertension.
  • The participant has portal vein thrombosis, transjugular intrahepatic portosystemic shunt, or surgical portosystemic shunt.
  • Severe ascites, except for participants in severe HI cohort, if the participant is medically stable, in the opinion of the Investigator or designee.
  • Participants with ALT or AST >5x ULN at screening, with a single repeat permitted to assess eligibility, if needed.
  • For Healthy Participants:
  • The participant must be excluded from participating in the study if the participant:
  • Is mentally or legally incapacitated or has significant emotional problems at the time of screening or expected during the conduct of the study.
  • Has history or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator or designee.
  • Has history of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
  • Has a history of any of the following:
  • Active infection or febrile illness within 7 days prior to dosing, as assessed by the Investigator or designee.
  • Symptoms suggestive of systemic or invasive infection requiring hospitalization or treatment within 8 weeks prior to dosing.
  • Chronic or recurrent bacterial disease, including but not limited to chronic pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or chronic skin ulcerations/infections or fungal infections (except superficial nailbed mycosis).
  • An infected joint prosthesis unless that prosthesis has been removed or replaced within 60 days prior to dosing.
  • Opportunistic infections (e.g., Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).
  • Cancer or lymphoproliferative disease within 5 years prior to dosing, with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix is not exclusionary.
  • Known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy.
  • Liver or other solid organ transplant.
  • Has history or presence of alcoholism and/or drug abuse within the past 2 years prior to dosing, as determined by the Investigator or designee.
  • Has history or presence of clinically significant hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
  • Female with a positive pregnancy test or who is lactating.
  • Has ECG abnormalities that are considered clinically significant and would pose an unacceptable risk to the participant if he or she participated in the study, in the opinion of the Investigator or designee.
  • Has positive results for the urine or saliva drug screen at screening or check-in, unless the positive drug screen is due to prescription drug use that is approved by the Investigator or designee and Sponsor.
  • Has positive results for urine or breath alcohol screen at screening or check-in.
  • Unable to refrain from or anticipates the use of any medication or substance (including prescription or over-the-counter, vitamin supplements, natural or herbal supplements).
  • Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to dosing and throughout the study.
  • Has made a donation of blood or had significant blood loss within 56 days prior to dosing.
  • Has made a plasma donation within 7 days prior to dosing.
  • Participated in another clinical study within 30 days prior to dosing. The 30-day window will be derived from the date of the last dosing in the previous study to Day 1 of the current study.
  • Herpes infections:
  • Participant has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 (demonstrated on physical examination and/or medical history) at screening or Day 1.
  • Participant has history of serious herpetic infection that includes any episode of disseminated disease, multidermatomal herpes simplex virus, herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (defined as 2 episodes within 2 years).
  • Positive results for non-herpetic viral diseases at screening:
  • HCV antibody and a positive confirmatory test result for HCV RNA (nucleic acid test or PCR).
  • HBsAg+, hepatitis B virus DNA, or HBcAb+ with positive hepatitis B virus DNA.
  • HIV.
  • TB:
  • Has history of active TB infection, regardless of treatment status.
  • Has signs or symptoms of active TB (including but not limited to chronic fever, chronic productive cough, night sweats, or weight loss) as judged by the Investigator or designee.
  • Has evidence of LTBI as evidenced by a positive QFT result OR 2 indeterminant QFT results and does not have documentation of appropriate LTBI prophylaxis. Participant remains eligible if he or she can provide documentation of prior and complete treatment for LTBI (appropriate in duration and type per current local country guidelines).
  • Has had any imaging study during or 6 months prior to screening, including x-ray, chest computed tomography, magnetic resonance imaging, or other chest imaging suggesting evidence of current active or a history of active TB.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Miami

    Miami, Florida, 33146

  • Orlando Clinical Research Center

    Orlando, Florida, 32809

  • American Research Corporation - Texas Liver Institute

    San Antonio, Texas, 78215

  • Pinnacle Clinical Research - San Antonio

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: An Open-Label, Phase 1 Study to Compare Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of TAK-279 in Subjects With or Without Hepatic Impairment

The main aim of this study is to find out how the body processes 1 dose of TAK-279 (pharmacokinetics) in participants with liver problems compared to participants without liver problems. Other aims are to check for side effects from TAK-279 and to learn how well participants tolerate 1 dose of TAK-279.

The participants will need to stay at the clinic for 11 days.

Read the detailed description

The drug being tested in this study is called TAK-279. The study will assess the safety and tolerability of single oral dose of TAK-279 in participants with moderate (Part A) and mild or severe (Part B) hepatic impairment (HI) compared to healthy participants with normal hepatic function.

The study will enroll up to 32 participants. Participants will be assigned to following study arms:

  • Cohort 1, Moderate HI: TAK-279 50 mg
  • Cohort 2, Normal Hepatic Function: TAK-279 50 mg
  • Cohort 3, Mild/Severe HI: TAK-279 50 mg

This multi-center trial will be conducted in the United States. The overall duration of the study is approximately 42 days. Participants will be followed up for 14 days after the last dose of study drug for a follow-up assessment.

Being tested
TAK-279
Keywords
Drug Therapy

What participants receive

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

  • TAK-279Drug

    TAK-279 capsules.

Study groups in NCT05976321
Study groupRoleWhat they receive
Cohort 1, Moderate HI: TAK-279 50 mgExperimentalParticipants with moderate HI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study.
Receives: Drug: TAK-279
Cohort 2, Normal Hepatic Function: TAK-279 50 mgExperimentalParticipants with normal hepatic function will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study. Based on an evaluation of the results from Part A, additional participants with normal hepatic function may be enrolled in Part B of the study.
Receives: Drug: TAK-279
Cohort 3, Mild/Severe HI: TAK-279 50 mgExperimentalParticipants with mild/severe HI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part B of the study based on an evaluation of the results from Part A.
Receives: Drug: TAK-279

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-279

    Measured: Predose and at multiple time points post dose from Days 1 to 10

  2. AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-279

    Measured: Predose and at multiple time points post dose from Days 1 to 10

  3. AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-279

    Measured: Predose and at multiple time points post dose from Days 1 to 10

Secondary outcomes (9)

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.

    Measured: Up to 14 days

  2. Number of Participants With Adverse Events of Special Interest (AESIs)

    Measured: Up to 14 days

  3. Number of Participants With Clinically Significant Vital Signs

    Measured: Up to 10 days

  4. Number of Participants With Clinically Significant Electrocardiogram Findings

    Measured: Up to 10 days

  5. Number of Participants With Clinically Significant Laboratory Values

    Measured: Up to 10 days

  6. Number of Participants With Clinically Significant Physical Examination Findings

    Measured: Up to 10 days

  7. Cmax,u: Maximum Observed Unbound TAK-279 Plasma Concentration

    Measured: Post dose at multiple timepoints from Day 1 to Day 2

  8. AUClast,u: Area Under the Unbound Drug Concentration-time Curve, From Time 0 to the Last Quantifiable Concentration of TAK-279

    Measured: Post dose at multiple timepoints from Day 1 to Day 2

  9. AUC∞,u: Area Under the Unbound Drug Concentration-time Curve, From Time 0 to Infinity of TAK-279

    Measured: Post dose at multiple timepoints from Day 1 to Day 2

Timeline

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

  1. First posted4 Aug 2023
  2. Study start22 Sep 2023
  3. Primary completion15 Apr 2024
  4. Study completion15 Apr 2024

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05976321
Sponsor's protocol ID
TAK-279-1004
Status last verified
Aug 2024
First submitted
28 Jul 2023
Last updated
29 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAK-279 in people with Hepatic Impairment and Healthy Volunteers, run by Takeda at 4 sites 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 27 inclusion and 81 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 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Cmax: Maximum Observed Plasma Concentration for TAK-279 (time frame: Predose and at multiple time points post dose from Days 1 to 10). The study lists 3 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 NCT05976321.

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 29 Aug 2024.

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