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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights
Study Summary
This trial tests how TAK-279 is processed by the body and how it interacts with other substances. Participants must stay at a clinic for up to 26 days.
Who is the study for?
Healthy adults aged 18-55, with a normal heart rate and kidney function, who don't smoke and have a BMI between 18.0 and 32.0 kg/m^2 can join this trial. They must not have significant medical issues or infections recently, no history of drug abuse or alcoholism in the past two years, and cannot be at risk for suicide.Check my eligibility
What is being tested?
The study is testing how TAK-279 is processed by healthy adults when taken with other substances that affect metabolism like erythromycin (an antibiotic), phenytoin (a seizure medication), and efavirenz (an antiviral). Participants will stay at the clinic for up to 26 days to monitor TAK-279's effects alone and combined.See study design
What are the potential side effects?
Possible side effects may include reactions related to the immune system due to interactions between TAK-279 and metabolism-affecting drugs. Specific side effects are not listed but monitoring will assess tolerance levels of participants.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Parts 1, 2, and 3: AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-279
Parts 1, 2, and 3: Cmax: Maximum Observed Plasma Concentration for TAK-279
Secondary outcome measures
Parts 1, 2, and 3: Number of Participants with Abnormal Electrocardiogram Findings
Parts 1, 2, and 3: Number of Participants with Abnormal Laboratory Values
Parts 1, 2, and 3: Number of Participants with Abnormal Vital Signs
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mgExperimental Treatment2 Interventions
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.
Group II: Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mgExperimental Treatment2 Interventions
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.
Group III: Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mgExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Efavirenz
2005
Completed Phase 4
~11160
Erythromycin
2015
Completed Phase 4
~1590
TAK-279
2023
Completed Phase 1
~180
Phenytoin
2023
Completed Phase 4
~830
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
TakedaLead Sponsor
1,202 Previous Clinical Trials
4,178,090 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,207 Previous Clinical Trials
489,508 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a severe infection that required hospitalization or treatment within the last 8 weeks before starting the study.You have long-lasting or repeat bacterial infections in your body like kidney or bladder infections, lung infections, bone infections, or persistent skin infections.You have an active infection caused by a germ that usually doesn't cause problems in healthy people but can be dangerous if your immune system is weakened.You have a history of seizures, epilepsy, severe head injury, multiple sclerosis, or other neurological conditions that doctors believe are important for this study.Your seated pulse rate must be between 40 and 99 beats per minute at the screening visit.Your eGFR at the screening visit must be 80 mL/min/1.73m2 or higher.You had cancer or a disease affecting your lymph nodes within the past 5 years before starting the study.You do not have abnormally low levels of potassium or magnesium at the screening visit.You are medically well with no notable medical history, physical examination, laboratory results, vital signs and ECGs as judged by the Investigator or their delegate.The electrocardiogram (ECG) findings are normal or insignificant according to the Investigator's or designated person's assessment during the screening visit.To provide an accurate summary, I would need the specific criteria you are referring to. Please provide the complete list of criteria you would like me to summarize.You comprehend the ICF and are capable of adhering to the study protocol.You are a healthy adult of either gender, aged between 18 and 55 years old, who is not able to bear children.Male participants must adhere to the contraception guidelines outlined.You are a non-smoker who has refrained from nicotine and tobacco products for three months preceding the initial dose, as reported by yourself.You have a BMI between 18.0 and 32.0 kg/m^2 at the time of screening.Your seated blood pressure is between 90/40 mmHg and 140/90 mmHg at the screening visit.The QTcF interval is no greater than 450 milliseconds, and the ECG findings are considered normal or insignificant by the Investigator or designee at screening.At screening and check-in, your liver function tests such as ALT, AST, ALP, and total bilirubin must be at or below the ULN.
Research Study Groups:
This trial has the following groups:- Group 1: Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg
- Group 2: Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg
- Group 3: Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an age limit for participating in this experiment?
"This medical trial is only open to patients aged between 18 and 55. In contrast, there are 55 clinical trials for those under 18 and 382 specifically targeting individuals over 65 years of age."
Answered by AI
Who qualifies to take part in this research trial?
"The research team require 48 individuals who are physically sound and aged 18-55 to be involved in this medical trial."
Answered by AI
How perilous is the combination of TAK-279 50 mg and Erythromycin 500 mg for Part 1, Treatment A + Treatment B?
"Power's evaluation team placed TAK-279 50 mg + Erythromycin 500 mg at a 1 on the safety scale, given that it is in Phase 1 and there are only limited studies supporting its effectiveness."
Answered by AI
Is enrollment for this study currently available?
"According to clinicaltrials.gov, this investigation is no longer recruiting participants as it was last updated on August 9th 2023 after being posted on the 11th of August that same year. Despite this trial's conclusion, 805 alternative studies are actively seeking new enrollees presently."
Answered by AI
Who else is applying?
What site did they apply to?
Celerion - Tempe, AZ Site
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Most responsive sites:
- Celerion - Tempe, AZ Site: < 48 hours
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