Healthy VolunteersPhase 1NCT05995249
A Study of the Interaction of TAK-279 With Substances That Have an Impact on Metabolism in Healthy Adults
A Phase 1 study testing TAK-279, Erythromycin and Phenytoin in people with Healthy Volunteers, run by Takeda at 1 site in United States.
Trial summary
The main aim of this study is to find out how the body of a healthy adult processes TAK-279 (pharmacokinetics) when substances that either hinder or help the human metabolism such as erythromycin, phenytoin and efavirenz are given along with TAK-279. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TAK-279, Erythromycin and Phenytoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2023to 31 Dec 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
- Healthy, adult, male or female of non-childbearing potential, 18-55 years of age, inclusive, at the screening visit.
- Male participants must follow protocol specified contraception guidance.
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m^2 at the screening visit.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and electrocardiograms (ECGs), as deemed by the Investigator or designee, including the following:
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- Seated blood pressure (BP) is ≥ 90/40 millimeter of mercury (mmHg) and ≤ 140/90 mmHg at the screening visit.
- Seated pulse rate is ≥ 40 beats per minute (bpm) and ≤ 99 bpm at the screening visit.
- Part 1 only: QTcF interval is ≤ 450 msec (males and females) and has ECG findings considered normal or not clinically significant by the Investigator or designee at the screening visit.
- Part 2 and 3: ECG findings considered normal or not clinically significant by the Investigator or designee at the screening visit.
- Estimated glomerular filtration rate (eGFR) ≥ 80 mL/min/1.73m^2 at the screening visit.
- Liver function tests including Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP), and total bilirubin ≤ upper limit of normal (ULN) at the screening visit and at check-in.
- No clinically significant hypokalemia or hypomagnesemia at the screening visit.
Who cannot join
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator or designee.
- 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 first dosing, as assessed by the Investigator or designee.
- Symptoms suggestive of systemic or invasive infection requiring hospitalization or treatment within 8 weeks prior to first dosing.
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- 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 greater than 60 days prior to first dosing.
- Opportunistic infections (eg, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).
- Cancer or lymphoproliferative disease within 5 years prior to first 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 first dosing, as determined by the Investigator or designee.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs, including macrolide antibiotics (Part 1 only; eg, erythromycin) or anti-seizure agents (Part 2 only; eg, phenytoin) or anti-viral drugs (Part 3 only; eg, efavirenz).
- Part 2 and Part 3 only: Any positive responses on the Columbia-Suicide Severity Rating Scale (C-SSRS) or has a risk of suicide according to the Investigator's or designee judgment based on the assessment of the C-SSRS at the screening visit or check-in or has made a suicide attempt within 12 months before the first dosing.
- Part 2 only: History of seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions which the Investigator or designee considers to be clinically significant.
- Part 2 only: Participant is known to be a CYP2C9 and/or CYP2C19 poor metabolizer based on genotyping prior to screening or is determined to be a CYP2C9 and/or CYP2C19 poor metabolizer at the screening visit.
- History or presence of ventricular dysfunction or risk factors for Torsades de Pointes (eg, heart failure, cardiomyopathy, family history of Long QT Syndrome).
- Female participant of childbearing potential.
- Female participant with a positive pregnancy test at the screening visit or at check-in or who is lactating.
- Positive urine drug or alcohol results at the screening visit or check-in.
- Unable to refrain from or anticipates the use of:
- Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing.
- Any drugs known to be moderate or strong inducers of CYP3A4 enzymes and/or P-glycoprotein (P-gp), including St. John's Wort, for 28 days prior to the first dosing. Appropriate sources (eg, Flockhart Table™) including the product label for erythromycin (Erythromycin Tablets USP 2018), phenytoin (DILANTIN (extended phenytoin sodium capsules) 2022), and efavirenz (SUSTIVA (efavirenz) capsules and tablets 2019) will be consulted to confirm lack of pharmacokinetic (PK)/pharmacodynamic interaction with the study drugs.
- 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 first dosing and throughout the study.
- Has made a donation of blood or had significant blood loss within 56 days prior to first dosing.
- Has made a plasma donation within 7 days prior to first dosing.
- Participated in another clinical study within 30 days prior to first dosing. The 30 day window will be derived from the date of the last dosing in the previous study to Day 1 of Period 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 of Period 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 the screening visit:
- 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 HBcAb+ with positive hepatitis B virus DNA;
- Human immunodeficiency virus (HIV).
- Positive results for tuberculosis (TB) at the screening visit or has the following:
- 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 QFT result OR 2 indeterminant Quantiferon TB Gold (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.
- Part 3 only: History of amphetamine and methylphenidate use; history or presence of sleeping disorders or sleeping irregularities, or any significant cardiac abnormality in the opinion of the Investigator or designee.
- Part 2 and Part 3 only: History or presence of Stevens-Johnson Syndrome and/or seizures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, 3-Part, Open-label, Drug-Drug Interaction Study to Evaluate the Effect of a Moderate CYP3A4 Inhibitor, and of Strong and Moderate CYP3A4 Inducers on the Pharmacokinetics of TAK-279 in Healthy Subjects
The main aim of this study is to find out how the body of a healthy adult processes TAK-279 (pharmacokinetics) when substances that either hinder or help the human metabolism such as erythromycin, phenytoin and efavirenz are given along with TAK-279. Other aim is to learn about side effects and how well it is tolerated when TAK-279 is given alone and together with substances that impact human metabolism.
The participants will need to stay at the clinic for up to 26 days.
Read the detailed description
The drug being tested in this study is called TAK-279. TAK-279 is being tested to assess the effect of a moderate CYP3A4 inhibitor (erythromycin- Part 1), and of strong (phenytoin- Part 2) and moderate (efavirenz- Part 3) CYP3A4 inducers on the pharmacokinetics of TAK-279 in healthy participants.
The study will enroll approximately 48 patients. Participants will be enrolled in one of the three parts to receive a single dose of TAK-279 in both Period 1 and Period 2 along with multiple doses of either erythromycin, phenytoin or efavirenz in Period 2 as given below:
- Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg
- Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg
- Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg
All participants will be monitored for up to 14 days postdose in each Part.
This single-center trial will be conducted in the United States. The overall study duration is approximately 65 days for Part 1, 73 days for Part 2, and 70 days for Part 3.
- Conditions
- Healthy Volunteers
- Being tested
- TAK-279, Erythromycin, Phenytoin, Efavirenz
- 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
ErythromycinDrug
Erythromycin tablets
PhenytoinDrug
Phenytoin capsules
EfavirenzDrug
Efavirenz tablets
| Study group | Role | What they receive |
|---|---|---|
| Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg | Experimental | Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg, on Day 5 and erythromycin 500 mg orally thrice daily (TID) on Day 1 through Day 10 of Period 2 in Part 1 of the study. Receives: Drug: TAK-279; Drug: Erythromycin |
| Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg | Experimental | Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg on Day 14 and phenytoin 100 mg orally TID on Day 1 through Day 18 of Period 2 in Part 2 of the study. Receives: Drug: TAK-279; Drug: Phenytoin |
| Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg | Experimental | Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg on Day 11 and efavirenz 600 mg orally once daily (QD) on Day 1 through Day 15 of Period 2 in Part 3 of the study. Receives: Drug: TAK-279; Drug: Efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts 1, 2, and 3: Cmax: Maximum Observed Plasma Concentration for TAK-279
Measured: Predose and at multiple timepoints post dose from Day 1 period 1 (length= 6 days) to period 2 Day 11 in Part 1 (length= 11 days), up to period 2 Day 19 in Part 2 (length= 19 days) and up to period 2 Day 16 in Part 3 (length= 16 days)
Parts 1, 2, and 3: AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-279
Measured: Predose and at multiple timepoints post dose from Day 1 period 1 (length= 6 days) to period 2 Day 11 in Part 1 (length= 11 days), up to period 2 Day 19 in Part 2 (length= 19 days) and up to period 2 Day 16 in Part 3 (length= 16 days)
Parts 1, 2, and 3: 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 timepoints post dose from Day 1 period 1 (length= 6 days) to period 2 Day 11 in Part 1 (length= 11 days), up to period 2 Day 19 in Part 2 (length= 19 days) and up to period 2 Day 16 in Part 3 (length= 16 days)
Secondary outcomes (4)
Parts 1, 2, and 3: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: From Day 1 of period 1 through period 2 Day 11 (up to approximately 65 days) in Part 1, up to period 2 Day 19 (up to approximately 73 days) in Part 2 and up to period 2 Day 16 (up to approximately 70 days) in Part 3
Parts 1, 2, and 3: Number of Participants with Abnormal Vital Signs
Abnormal vital sign assessment will include assessments of systolic and diastolic blood pressure, pulse rate, respiration rate, body temperature as determined by the investigator.
Measured: From Day 1 of period 1 through period 2 Day 11 (up to approximately 65 days) in Part 1, up to period 2 Day 19 (up to approximately 73 days) in Part 2 and up to period 2 Day 16 (up to approximately 70 days) in Part 3
Parts 1, 2, and 3: Number of Participants with Abnormal Electrocardiogram Findings
Abnormal 12-lead ECG findings will include heart rate and measures PR, QRS, QT and QTcF intervals. 12-lead ECG recordings were obtained after the participants have rested for at least 5 minutes in supine position as determined by the investigator.
Measured: From Day 1 of period 1 through period 2 Day 11 (up to approximately 65 days) in Part 1, up to period 2 Day 19 (up to approximately 73 days) in Part 2 and up to period 2 Day 16 (up to approximately 70 days) in Part 3
Parts 1, 2, and 3: Number of Participants with Abnormal Laboratory Values
Abnormal laboratory investigation will include hematology, chemistry, and urinalysis analysis as determined by the investigator.
Measured: From Day 1 of period 1 through period 2 Day 11 (up to approximately 65 days) in Part 1, up to period 2 Day 19 (up to approximately 73 days) in Part 2 and up to period 2 Day 16 (up to approximately 70 days) in Part 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start11 Aug 2023
- Primary completion18 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995249
- Sponsor's protocol ID
- TAK-279-1002
- Status last verified
- Feb 2024
- First submitted
- 9 Aug 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 3-Part, Open-label, Drug-Drug Interaction Study to Evaluate the Effect of a Moderate CYP3A4 Inhibitor, and of Strong and Moderate CYP3A4 Inducers on the Pharmacokinetics of TAK-279 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05995249
- Acronym / sponsor ID
- TAK-279-1002
- Conditions
- Healthy Volunteers
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2023 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 16 Aug 2023 (actual)
- 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 main aim of this study is to find out how the body of a healthy adult processes TAK-279 (pharmacokinetics) when substances that either hinder or help the human metabolism such as erythromycin, phenytoin and efavirenz are given along with TAK-279. Other aim is to learn about side effects and how well it is tolerated when TAK-279 is given alone and together with substances that impact human metabolism.
The participants will need to stay at the clinic for up to 26 days.
Detailed description
The drug being tested in this study is called TAK-279. TAK-279 is being tested to assess the effect of a moderate CYP3A4 inhibitor (erythromycin- Part 1), and of strong (phenytoin- Part 2) and moderate (efavirenz- Part 3) CYP3A4 inducers on the pharmacokinetics of TAK-279 in healthy participants.
The study will enroll approximately 48 patients. Participants will be enrolled in one of the three parts to receive a single dose of TAK-279 in both Period 1 and Period 2 along with multiple doses of either erythromycin, phenytoin or efavirenz in Period 2 as given below:
- Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg
- Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg
- Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg
All participants will be monitored for up to 14 days postdose in each Part.
This single-center trial will be conducted in the United States. The overall study duration is approximately 65 days for Part 1, 73 days for Part 2, and 70 days for Part 3.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg | Experimental | Drug: TAK-279, Drug: ErythromycinParticipants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg, on Day 5 and erythromycin 500 mg orally thrice daily (TID) on Day 1 through Day 10 of Period 2 in Part 1 of the study. |
| Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg | Experimental | Drug: TAK-279, Drug: PhenytoinParticipants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg on Day 14 and phenytoin 100 mg orally TID on Day 1 through Day 18 of Period 2 in Part 2 of the study. |
| Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg | Experimental | Drug: TAK-279, Drug: EfavirenzParticipants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg on Day 11 and efavirenz 600 mg orally once daily (QD) on Day 1 through Day 15 of Period 2 in Part 3 of the study. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
- Healthy, adult, male or female of non-childbearing potential, 18-55 years of age, inclusive, at the screening visit.
- Male participants must follow protocol specified contraception guidance.
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m^2 at the screening visit.
Key exclusion criteria (42 listed)
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator or designee.
- 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:
- Has history or presence of alcoholism and/or drug abuse within the past 2 years prior to first dosing, as determined by the Investigator or designee.
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 |
|---|---|---|
| TAK-279TAK-279 capsules | Drug | Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg, Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg, Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg |
| ErythromycinErythromycin tablets | Drug | Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg |
| PhenytoinPhenytoin capsules | Drug | Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg |
| EfavirenzEfavirenz tablets | Drug | Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg |
Primary outcome
Parts 1, 2, and 3: Cmax: Maximum Observed Plasma Concentration for TAK-279
Time frame: Predose and at multiple timepoints post dose from Day 1 period 1 (length= 6 days) to period 2 Day 11 in Part 1 (length= 11 days), up to period 2 Day 19 in Part 2 (length= 19 days) and up to period 2 Day 16 in Part 3 (length= 16 days)
Parts 1, 2, and 3: AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-279
Time frame: Predose and at multiple timepoints post dose from Day 1 period 1 (length= 6 days) to period 2 Day 11 in Part 1 (length= 11 days), up to period 2 Day 19 in Part 2 (length= 19 days) and up to period 2 Day 16 in Part 3 (length= 16 days)
Parts 1, 2, and 3: AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for TAK-279
Time frame: Predose and at multiple timepoints post dose from Day 1 period 1 (length= 6 days) to period 2 Day 11 in Part 1 (length= 11 days), up to period 2 Day 19 in Part 2 (length= 19 days) and up to period 2 Day 16 in Part 3 (length= 16 days)
4 secondary outcomes
Parts 1, 2, and 3: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: From Day 1 of period 1 through period 2 Day 11 (up to approximately 65 days) in Part 1, up to period 2 Day 19 (up to approximately 73 days) in Part 2 and up to period 2 Day 16 (up to approximately 70 days) in Part 3
Parts 1, 2, and 3: Number of Participants with Abnormal Vital Signs
Time frame: From Day 1 of period 1 through period 2 Day 11 (up to approximately 65 days) in Part 1, up to period 2 Day 19 (up to approximately 73 days) in Part 2 and up to period 2 Day 16 (up to approximately 70 days) in Part 3
Parts 1, 2, and 3: Number of Participants with Abnormal Electrocardiogram Findings
Time frame: From Day 1 of period 1 through period 2 Day 11 (up to approximately 65 days) in Part 1, up to period 2 Day 19 (up to approximately 73 days) in Part 2 and up to period 2 Day 16 (up to approximately 70 days) in Part 3
Parts 1, 2, and 3: Number of Participants with Abnormal Laboratory Values
Time frame: From Day 1 of period 1 through period 2 Day 11 (up to approximately 65 days) in Part 1, up to period 2 Day 19 (up to approximately 73 days) in Part 2 and up to period 2 Day 16 (up to approximately 70 days) in Part 3
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 6 Feb 2024.
- To obtain more information about this study, click this linkLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Screening Protocol
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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.
Study Director study director
Takeda
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 TAK-279, Erythromycin and Phenytoin in people with Healthy Volunteers, run by Takeda 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 13 inclusion and 42 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 6 Feb 2024. 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?
Parts 1, 2, and 3: Cmax: Maximum Observed Plasma Concentration for TAK-279 (time frame: Predose and at multiple timepoints post dose from Day 1 period 1 (length= 6 days) to period 2 Day 11 in Part 1 (length= 11 days), up to period 2 Day 19 in Part 2 (length= 19 days) and up to period 2 Day 16 in Part 3 (length= 16 days)). 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?
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 6 Feb 2024.