Healthy VolunteersPhase 1NCT06258265
A Study of TAK-279 in Healthy Adults on the Effect on ECG Measurements
A Phase 1 study testing TAK-279 and Moxifloxacin 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 more than one dose of TAK-279 changes the heart-rate corrected QT (QTc) interval of healthy adults. A QTc interval is a measurement on an electrocardiogram (ECG) and shows the time when the heart contracts until it finishes relaxing. 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 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2024to 9 Jul 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Understand the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.
- Healthy, adult, male or female, 18-55 years of age, inclusive, at the screening visit.
- Female participants of childbearing potential and non-sterilized male participants must follow protocol specified contraception guidance as described in protocol.
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first baseline cardiodynamic measurement (Day -1) based on participant self-reporting.
- BMI greater than or equal to (>=) 18.0 and less than or equal to (<=) 32.0 kilograms per meter square (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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- Supine blood pressure is >=90/40 millimeter of mercury (mmHg) and <=140/90 mmHg at the screening visit.
- Supine pulse rate is >=40 beats per minute (bpm) and <=99 bpm at the screening visit.
- QTc using Fridericia's formula (QTcF) interval is <=450 milliseconds (msec) (males) and <=460 msec (female) at the screening visit.
- QRS interval <=110 msec at the screening visit (if >110 msec, result will be confirmed by a manual over read).
- PR interval <=220 msec at the screening visit.
- eGFR >=80 milliliter per minute per 1.73 meter square (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.
- Creatine phosphokinase (CPK) <=ULN at the screening visit and at check-in.
- Amylase and lipase <=ULN at the screening visit and at check-in.
- No clinically significant hypokalemia, hypomagnesemia, or other electrolyte abnormalities at the screening visit.
- Able to swallow multiple capsules.
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 baseline cardiodynamic measurement (Day -1), as assessed by the Investigator or designee.
- Symptoms suggestive of systemic or invasive infection requiring hospitalization or treatment within 8 weeks prior to first baseline cardiodynamic measurement (Day -1).
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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 baseline cardiodynamic measurement (Day -1).
- Opportunistic infections (eg, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).
- Cancer or lymphoproliferative disease, with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
- Known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy.
- Liver, kidney, heart, or other solid organ transplant.
- Myasthenia gravis.
- Peripheral neuropathy.
- Has history or presence of alcoholism and/or drug abuse within the past 2 years prior to first baseline cardiodynamic measurement (Day -1), as determined by the Investigator or designee.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs.
- Allergy to band aids, adhesive dressing, or medical tape.
- History or presence of any of the following, deemed clinically relevant by the Investigator or designee at the screening visit or at check-in:
- Cardiac disease; arrhythmias, presyncope, or syncopal episodes; heart failure, heart disease or risk factors for torsades de pointes (including long QT syndrome or family history of long QT syndrome).
- Sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, history of cardiac arrhythmia, prolonged QTcF interval, or conduction abnormalities.
- Ischemic heart disease, poorly controlled hypertension, or other cardiovascular disorder
- T wave flattening or other abnormalities which in the opinion of the Investigator or designee may interfere with the analysis of QT intervals.
- A family history of sudden cardiac death.
- Female participant with a positive pregnancy test at the screening visit or at check-in or who is breastfeeding and/or lactating.
- Positive urine drug or alcohol results at the screening visit or at check-in.
- Positive Coronavirus disease 2019 (COVID-19) result at check-in.
- Unable to refrain from or anticipates the use of:
- Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements, including any cytochrome P450 (CYP)3A4 inhibitors, beginning 14 days prior to the first baseline cardiodynamic measurement (Day -1).
- Any drugs known to be inducers of CYP3A4 enzymes and/or P-glycoprotein (P-gp), including St. John's Wort, for 28 days prior to the first baseline cardiodynamic measurement (Day -1). Appropriate sources (eg, Flockhart Table™) including the product label for moxifloxacin will be consulted to confirm lack of pharmacokinetic (PK)/pharmacodynamic interaction with the study drugs.
- Any drugs known to prolong the QT/QTc interval for 28 days or 5 half-lives (whichever is longer) prior to the first baseline cardiodynamic measurement (Day -1).
- 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 baseline cardiodynamic measurement (Day -1) and throughout the study.
- Has made a donation of blood or had significant blood loss within 56 days prior to first baseline cardiodynamic measurement (Day -1).
- Has made a plasma donation within 7 days prior first baseline cardiodynamic measurement (Day -1).
- Participated in another clinical study within 30 days prior to first baseline cardiodynamic measurement (Day -1). 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:
- Has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 (demonstrated on physical examination and/or medical history) at the screening visit or check-in.
- Has history of serious herpetic infection that includes any episode of disseminated disease, multidermatomal herpes zoster 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]).
- Hepatitic 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).
- Positive results for tuberculosis (TB) at the screening visit or has any of 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 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 prior to the screening visit, 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
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel Design Thorough QT Study With Nested Crossover to Investigate the Potential of TAK-279 to Prolong the QTc Interval in Adult Healthy Subjects
The main aim of this study is to find out how more than one dose of TAK-279 changes the heart-rate corrected QT (QTc) interval of healthy adults. A QTc interval is a measurement on an electrocardiogram (ECG) and shows the time when the heart contracts until it finishes relaxing. Other aims are to learn about the effect of several doses of TAK-279 on other ECG measurements of healthy adults, how the body of a healthy adult processes TAK-279 and moxifloxacin (pharmacokinetics), and to learn about the side effects of TAK-279 and how well it is tolerated when given to healthy adults.
The participants will be given TAK-279 and moxifloxacin or a placebo for 7 days.
During the study, participants will need to stay at the clinic for 10 days.
- Conditions
- Healthy Volunteers
- Being tested
- TAK-279, TAK-279 Placebo, Moxifloxacin, Moxifloxacin Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-279Drug
TAK-279 capsule.
TAK-279 PlaceboDrug
TAK-279 matching placebo capsule.
MoxifloxacinDrug
Moxifloxacin over-encapsulated tablet.
Moxifloxacin PlaceboDrug
Moxifloxacin matching placebo capsule.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, Therapeutic Dose Cohort: TAK-279 + TAK-279 Placebo + Moxifloxacin Placebo | Experimental | Participants will receive TAK-279 Dose 1 and matching placebo, capsules, once daily (QD) on Days 1 to 7 with moxifloxacin matching placebo, capsule, once on Days 1 and 8. Receives: Drug: TAK-279; Drug: TAK-279 Placebo; Drug: Moxifloxacin Placebo |
| Cohort 2, Supratherapeutic Dose Cohort: TAK-279 + Moxifloxacin Placebo | Experimental | Participants will receive TAK-279 Dose 2, capsules, QD on Days 1 to 7 with moxifloxacin matching placebo, capsule once on Days 1 and 8. Receives: Drug: TAK-279; Drug: Moxifloxacin Placebo |
| Cohort 3A, Control Cohort: Moxifloxacin + TAK-279 Placebo + Moxifloxacin Placebo | Experimental | Participants will receive moxifloxacin Dose 3, over-encapsulated tablet on Day 1 with TAK-279 matching placebo, QD on Days 1 to 7 and moxifloxacin placebo, capsule, once on Day 8. Receives: Drug: TAK-279 Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin Placebo |
| Cohort 3B, Control Cohort: TAK-279 Placebo + Moxifloxacin Placebo + Moxifloxacin | Experimental | Participants will receive moxifloxacin matching placebo, capsule on Day 1 with TAK-279 matching placebo, QD on Days 1 to 7 and moxifloxacin Dose 3, over-encapsulated tablet, once on Day 8. Receives: Drug: TAK-279 Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-corrected Change From Baseline in QTc Interval (ΔΔQTc) for TAK-279
Placebo-corrected QTc interval will be measured by continuous ECG recordings.
Measured: Baseline, Days 1, 7, and 8
Secondary outcomes (18)
Change From Baseline in Heart Rate (HR [ΔHR]) for TAK-279
HR will be measured by continuous ECG recordings.
Measured: Baseline, Days 1, 7, and 8
Change From Baseline in QTc (ΔQTc) Interval for TAK-279
QTc interval will be measured by continuous ECG recordings.
Measured: Baseline, Days 1, 7, and 8
Change From Baseline in PR Interval (ΔPR) for TAK-279
PR interval will be measured by continuous ECG recordings.
Measured: Baseline, Days 1, 7, and 8
Change From Baseline in QRS Interval (ΔQRS) for TAK-279
QRS interval will be measured by continuous ECG recordings.
Measured: Baseline, Days 1, 7, and 8
Placebo-corrected Change From Baseline in HR (ΔΔHR) for TAK-279
Placebo-corrected HR will be measured by continuous ECG recordings.
Measured: Baseline, Days 1, 7, and 8
Placebo-corrected Change From Baseline in ΔPR (ΔΔPR) for TAK-279
Placebo-corrected PR will be measured by continuous ECG recordings.
Measured: Baseline, Days 1, 7, and 8
Placebo-corrected Change From Baseline in QRS (ΔΔQRS) for TAK-279
Placebo-corrected QRS interval will be measured by continuous ECG recordings.
Measured: Baseline, Days 1, 7, and 8
Number of Participants With Categorical Outliers for HR, PR, QRS, and QTc for TAK-279
HR, PR, QRS, and QTc will be measured by continuous ECG recordings.
Measured: Baseline, Days 1, 7, and 8
Change From Baseline in Electrocardiogram (ECG) Morphology for TAK-279
ECG morphological analyses will be performed using the ECG waveform interpretation as defined by the central ECG laboratory's cardiologist.
Measured: Baseline, Days 1, 7, and 8
Placebo-corrected Change From Baseline in QTc Interval (ΔΔQTc) for Moxifloxacin
Placebo-corrected QTc interval will be measured by continuous ECG recordings.
Measured: Baseline, Days 1, 7, and 8
Maximum Observed Plasma Concentration (Cmax) of TAK-279 and Moxifloxacin
Measured: Days 1 (TAK-279 and Moxifloxacin) and 7 (TAK-279): Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose; Day 8 (Moxifloxacin): 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose
Time to Reach Cmax (tmax) of TAK-279 and Moxifloxacin
Measured: Days 1 (TAK-279 and Moxifloxacin) and 7 (TAK-279): Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose; Day 8 (Moxifloxacin): 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose
Area Under the Plasma Concentration-Time Curve During a Dosing Interval (tau) at Steady State (AUCτ) of TAK-279
Measured: Days 1 and 7: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 hours (AUC0-24) of Moxifloxacin
Measured: Day 1: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose; Day 8: 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs)
Measured: Baseline up to Day 22
Number of Participants With Markedly Abnormal Values (MAVs) in Vital signs Parameters
Vital signs assessment will include blood pressure, pulse rate, respiratory rate, and oral temperature parameters.
Measured: Baseline up to Day 9
Number of Participants With MAVs in 12-lead ECGs Measurement
ECGs will be performed with participants in a supine position.
Measured: Baseline up to Day 9
Number of Participants With MAVs in Clinical Laboratory Assessments
Clinical laboratory assessment will include includes hematology, chemistry, and urinalysis parameters.
Measured: Baseline up to Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start29 Apr 2024
- Primary completion25 Jun 2024
- Study completion9 Jul 2024
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 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
- NCT06258265
- Sponsor's protocol ID
- TAK-279-1001
- Status last verified
- Jul 2024
- First submitted
- 6 Feb 2024
- Last updated
- 11 Jul 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 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel Design Thorough QT Study With Nested Crossover to Investigate the Potential of TAK-279 to Prolong the QTc Interval in Adult Healthy Subjects
- ClinicalTrials.gov ID
- NCT06258265
- Acronym / sponsor ID
- TAK-279-1001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 14 Feb 2024 (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 more than one dose of TAK-279 changes the heart-rate corrected QT (QTc) interval of healthy adults. A QTc interval is a measurement on an electrocardiogram (ECG) and shows the time when the heart contracts until it finishes relaxing. Other aims are to learn about the effect of several doses of TAK-279 on other ECG measurements of healthy adults, how the body of a healthy adult processes TAK-279 and moxifloxacin (pharmacokinetics), and to learn about the side effects of TAK-279 and how well it is tolerated when given to healthy adults.
The participants will be given TAK-279 and moxifloxacin or a placebo for 7 days.
During the study, participants will need to stay at the clinic for 10 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, Therapeutic Dose Cohort: TAK-279 + TAK-279 Placebo + Moxifloxacin Placebo | Experimental | Drug: TAK-279, Drug: TAK-279 Placebo, Drug: Moxifloxacin PlaceboParticipants will receive TAK-279 Dose 1 and matching placebo, capsules, once daily (QD) on Days 1 to 7 with moxifloxacin matching placebo, capsule, once on Days 1 and 8. |
| Cohort 2, Supratherapeutic Dose Cohort: TAK-279 + Moxifloxacin Placebo | Experimental | Drug: TAK-279, Drug: Moxifloxacin PlaceboParticipants will receive TAK-279 Dose 2, capsules, QD on Days 1 to 7 with moxifloxacin matching placebo, capsule once on Days 1 and 8. |
| Cohort 3A, Control Cohort: Moxifloxacin + TAK-279 Placebo + Moxifloxacin Placebo | Experimental | Drug: TAK-279 Placebo, Drug: Moxifloxacin, Drug: Moxifloxacin PlaceboParticipants will receive moxifloxacin Dose 3, over-encapsulated tablet on Day 1 with TAK-279 matching placebo, QD on Days 1 to 7 and moxifloxacin placebo, capsule, once on Day 8. |
| Cohort 3B, Control Cohort: TAK-279 Placebo + Moxifloxacin Placebo + Moxifloxacin | Experimental | Drug: TAK-279 Placebo, Drug: Moxifloxacin, Drug: Moxifloxacin PlaceboParticipants will receive moxifloxacin matching placebo, capsule on Day 1 with TAK-279 matching placebo, QD on Days 1 to 7 and moxifloxacin Dose 3, over-encapsulated tablet, once on Day 8. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Understand the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.
- Healthy, adult, male or female, 18-55 years of age, inclusive, at the screening visit.
- Female participants of childbearing potential and non-sterilized male participants must follow protocol specified contraception guidance as described in protocol.
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first baseline cardiodynamic measurement (Day -1) based on participant self-reporting.
- BMI greater than or equal to (>=) 18.0 and less than or equal to (<=) 32.0 kilograms per meter square (kg/m^2) at the screening visit.
Key exclusion criteria (46 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 baseline cardiodynamic measurement (Day -1), 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 capsule. | Drug | Cohort 1, Therapeutic Dose Cohort: TAK-279 + TAK-279 Placebo + Moxifloxacin Placebo, Cohort 2, Supratherapeutic Dose Cohort: TAK-279 + Moxifloxacin Placebo |
| TAK-279 PlaceboTAK-279 matching placebo capsule. | Drug | Cohort 1, Therapeutic Dose Cohort: TAK-279 + TAK-279 Placebo + Moxifloxacin Placebo, Cohort 3A, Control Cohort: Moxifloxacin + TAK-279 Placebo + Moxifloxacin Placebo, Cohort 3B, Control Cohort: TAK-279 Placebo + Moxifloxacin Placebo + Moxifloxacin |
| MoxifloxacinMoxifloxacin over-encapsulated tablet. | Drug | Cohort 3A, Control Cohort: Moxifloxacin + TAK-279 Placebo + Moxifloxacin Placebo, Cohort 3B, Control Cohort: TAK-279 Placebo + Moxifloxacin Placebo + Moxifloxacin |
| Moxifloxacin PlaceboMoxifloxacin matching placebo capsule. | Drug | Cohort 1, Therapeutic Dose Cohort: TAK-279 + TAK-279 Placebo + Moxifloxacin Placebo, Cohort 2, Supratherapeutic Dose Cohort: TAK-279 + Moxifloxacin Placebo, Cohort 3A, Control Cohort: Moxifloxacin + TAK-279 Placebo + Moxifloxacin Placebo, Cohort 3B, Control Cohort: TAK-279 Placebo + Moxifloxacin Placebo + Moxifloxacin |
Primary outcome
Placebo-corrected Change From Baseline in QTc Interval (ΔΔQTc) for TAK-279
Time frame: Baseline, Days 1, 7, and 8
Placebo-corrected QTc interval will be measured by continuous ECG recordings.
18 secondary outcomes
Change From Baseline in Heart Rate (HR [ΔHR]) for TAK-279
Time frame: Baseline, Days 1, 7, and 8
Change From Baseline in QTc (ΔQTc) Interval for TAK-279
Time frame: Baseline, Days 1, 7, and 8
Change From Baseline in PR Interval (ΔPR) for TAK-279
Time frame: Baseline, Days 1, 7, and 8
Change From Baseline in QRS Interval (ΔQRS) for TAK-279
Time frame: Baseline, Days 1, 7, and 8
Placebo-corrected Change From Baseline in HR (ΔΔHR) for TAK-279
Time frame: Baseline, Days 1, 7, and 8
Placebo-corrected Change From Baseline in ΔPR (ΔΔPR) for TAK-279
Time frame: Baseline, Days 1, 7, and 8
Placebo-corrected Change From Baseline in QRS (ΔΔQRS) for TAK-279
Time frame: Baseline, Days 1, 7, and 8
Number of Participants With Categorical Outliers for HR, PR, QRS, and QTc for TAK-279
Time frame: Baseline, Days 1, 7, and 8
Change From Baseline in Electrocardiogram (ECG) Morphology for TAK-279
Time frame: Baseline, Days 1, 7, and 8
Placebo-corrected Change From Baseline in QTc Interval (ΔΔQTc) for Moxifloxacin
Time frame: Baseline, Days 1, 7, and 8
Maximum Observed Plasma Concentration (Cmax) of TAK-279 and Moxifloxacin
Time frame: Days 1 (TAK-279 and Moxifloxacin) and 7 (TAK-279): Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose; Day 8 (Moxifloxacin): 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose
Time to Reach Cmax (tmax) of TAK-279 and Moxifloxacin
Time frame: Days 1 (TAK-279 and Moxifloxacin) and 7 (TAK-279): Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose; Day 8 (Moxifloxacin): 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose
Area Under the Plasma Concentration-Time Curve During a Dosing Interval (tau) at Steady State (AUCτ) of TAK-279
Time frame: Days 1 and 7: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 hours (AUC0-24) of Moxifloxacin
Time frame: Day 1: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose; Day 8: 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs)
Time frame: Baseline up to Day 22
Number of Participants With Markedly Abnormal Values (MAVs) in Vital signs Parameters
Time frame: Baseline up to Day 9
Number of Participants With MAVs in 12-lead ECGs Measurement
Time frame: Baseline up to Day 9
Number of Participants With MAVs in Clinical Laboratory Assessments
Time frame: Baseline up to Day 9
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 11 Jul 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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Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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 and Moxifloxacin 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 17 inclusion and 46 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 11 Jul 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?
Placebo-corrected Change From Baseline in QTc Interval (ΔΔQTc) for TAK-279 (time frame: Baseline, Days 1, 7, and 8). 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 11 Jul 2024.