Healthy VolunteersPhase 1NCT06290050
A Study of the Interaction of Other Drugs With TAK-279 in Healthy Adults
A Phase 1 study testing Midazolam, Repaglinide and TAK-279 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 several doses of TAK-279 affects the body of healthy adults and processes midazolam and repaglinide (pharmacokinetics or PK). Another aim is to learn about the side effects of TAK-279 and how well it is tolerated when given to healthy adults either alone or together with… 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?
- Midazolam, Repaglinide and TAK-279
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2024to 16 May 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
- Participants must fulfill all of the following inclusion criteria to be eligible for participation in the study:
- Continuous non-smoker who has not used nicotine and tobacco containing products for at least 3 months prior to the first dosing based on subject self-reporting.
- Body mass index (BMI) greater than or equal to (>=) 18.0 and less than or equal to (<=) 32.0 kilogram per square meter (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:
- Seated blood pressure (BP) is >=90/40 millimeter of mercury (mmHg) and <=140/90 mmHg at the screening visit.
- Seated pulse rate (PR) is >=40 beats per minute (bpm) and <=99 bpm at the screening visit.
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- ECG findings considered normal or not clinically significant by the investigator or designee at the screening visit.
- Estimated glomerular filtration rate (eGFR) >=80 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) at the screening visit.
- Liver function tests including Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP), and total bilirubin <= ULN at the screening visit and at check-in.
Who cannot join
- Participants must not be enrolled in the study if they meet any of the following criteria:
- Fasting glucose >125 milligram per deciliter (mg/dL) at the screening visit.
- Has a history or presence 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.
- 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).
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- An infected joint prosthesis unless that prosthesis has been removed or replaced greater than 60 days prior to first dosing.
- Opportunistic infections (example, Pneumocystis jirovecii pneumonia, histoplasmosis, Coccidiomycosis) exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix is not exclusionary.
- 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.
- Solid organ transplant.
- Diabetes or prior episode(s) of hypoglycemia.
- 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.
- History or presence of ventricular dysfunction or risk factors for Torsades de Pointes (example, heart failure, cardiomyopathy, family history of Long QT Syndrome).
- 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 including any CYP3A4 and CYP2C8 inhibitors, beginning 14 days prior to the first dosing.
- Any drugs known to be inducers of CYP3A4 and CYP2C8 enzymes and/or P-gp, including St. John's Wort, for 28 days prior to the first dosing. Appropriate sources (example, Flockhart Table™) including the product label for midazolam and repaglinide will be consulted to confirm lack of PK/pharmacodynamic interaction with the study drugs.
- 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:
- 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 Day 1 of Period 1.
- 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);
- Hepatitis B surface antigen (HBsAg+), hepatitis B virus DNA, or Hepatitis B core antibody (HBcAb+) with positive hepatitis B virus Deoxyribonucleic acid (DNA);
- Human immunodeficiency virus (HIV).
- Positive results for 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 QuantiFERON TB Gold (QFT) result OR 2 indeterminant QFT results and does not have documentation of appropriate LTBI prophylaxis. Participants 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, Open-Label, Drug-Drug Interaction Study to Assess the Effect of TAK-279 on the Pharmacokinetics of a Sensitive CYP3A4 Substrate and a Sensitive CYP2C8 Substrate in Healthy Subjects
The main aim of this study is to find out how several doses of TAK-279 affects the body of healthy adults and processes midazolam and repaglinide (pharmacokinetics or PK). Another aim is to learn about the side effects of TAK-279 and how well it is tolerated when given to healthy adults either alone or together with midazolam or repaglinide.
During the study, participants will need to stay at the clinic for 19 days. Blood samples will be taken at several timepoints during the study. The study drug will be given by mouth (orally).
Read the detailed description
The drug being tested in this study is called TAK-279. The study will assess the potential effect of TAK-279 on cytochrome P450 (CYP) 3A4 using the probe substrate midazolam and the potential effect of TAK-279 on CYP2C8 using the probe substrate repaglinide in healthy participants.
The study will enroll approximately 20 participants. Participants will be enrolled in one of the four treatments.
- Treatment A: Midazolam 2 milligram (mg)
- Treatment B: Repaglinide 0.5 mg
- Treatment A + Treatment C: Midazolam 2 mg + TAK-279 Dose 1
- Treatment B + Treatment C: Repaglinide 0.5 mg + TAK-279 Dose 1
This single-center trial will be conducted in the United States. The overall study duration is approximately 59 days including screening period and follow-up.
- Conditions
- Healthy Volunteers
- Being tested
- Midazolam, Repaglinide, TAK-279
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Midazolam syrup.
RepaglinideDrug
Repaglinide tablets.
TAK-279Drug
TAK-279 capsules.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: Midazolam 2 mg | Experimental | Midazolam 2 mg (1 milliliter [mL] of 2 milligram per milliliter [mg/mL]), syrup, orally, on Day 1 of Period 1. Receives: Drug: Midazolam |
| Treatment B: Repaglinide 0.5 mg | Experimental | Repaglinide 0.5 mg (1*0.5 mg), tablets, orally, on Day 2 of Period 1. Receives: Drug: Repaglinide |
| Treatment C + Treatment A: TAK-279 Dose 1 + Midazolam 2 mg | Experimental | TAK-279 Dose 1, capsules, orally, on Days 1 through 15 of Period 2 followed by Midazolam 2 mg (1 mL of 2 mg/mL), syrup, orally, on Day 14 of Period 2. Receives: Drug: Midazolam; Drug: TAK-279 |
| Treatment C + Treatment B: TAK-279 Dose 1 + Repaglinide 0.5 mg | Experimental | TAK-279 Dose 1, capsules, orally, on Days 1 through 15 of Period 2 followed by Repaglinide 0.5 mg (1*0.5 mg), tablets, orally, on Day 15 of Period 2. Receives: Drug: Repaglinide; Drug: TAK-279 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: Maximum Observed Plasma Concentration for Midazolam and Repaglinide When Administered Alone and With TAK-279
Measured: Period 1-Midazolam Alone: Day 1 predose up to 24 hours (h) postdose; Repaglinide Alone: Day 2 predose up to 16 h postdose; Period 2-Midazolam, With TAK-279: Day 14 predose up to 24 h postdose; Repaglinide with TAK-279:Day 15 predose up to 16 h postdose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Midazolam and Repaglinide When Administered Alone and With TAK-279
Measured: Period 1-Midazolam Alone: Day 1 predose up to 24 hours (h) postdose; Repaglinide Alone: Day 2 predose up to 16 h postdose; Period 2-Midazolam, With TAK-279: Day 14 predose up to 24 h postdose; Repaglinide with TAK-279:Day 15 predose up to 16 h postdose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Midazolam and Repaglinide When Administered Alone and With TAK-279
Measured: Period 1-Midazolam Alone: Day 1 predose up to 24 hours (h) postdose; Repaglinide Alone: Day 2 predose up to 16 h postdose; Period 2-Midazolam, With TAK-279: Day 14 predose up to 24 h postdose; Repaglinide with TAK-279:Day 15 predose up to 16 h postdose
Secondary outcomes (1)
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI)
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. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. AESI (serious or nonserious) includes infections that are severe or serious; opportunistic; herpes virus; active tuberculosis (TB); or any infection requiring intravenous systemic therapy or immunomodulatory therapy, Creatine phosphokinase (CPK) elevation Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher (severe) greater than (>) 5* upper limit of normal (ULN), Liver injury, MACE (Major adverse cardiovascular events), Gastrointestinal perforation, Thromboembolic events, Malignancies including all malignancies, Nonmelanoma skin cancer (NMSC), and excluding NMSC and Lymphoma.
Measured: From Day 1 of Period 1 up to 14 days after the last dose of TAK-279 in Period 2 (up to 29 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start29 Mar 2024
- Primary completion3 May 2024
- Study completion16 May 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT06290050
- Sponsor's protocol ID
- TAK-279-1006
- Status last verified
- May 2024
- First submitted
- 21 Feb 2024
- Last updated
- 23 May 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Drug-Drug Interaction Study to Assess the Effect of TAK-279 on the Pharmacokinetics of a Sensitive CYP3A4 Substrate and a Sensitive CYP2C8 Substrate in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06290050
- Acronym / sponsor ID
- TAK-279-1006
- Conditions
- Healthy Volunteers
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2024 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 4 Mar 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 several doses of TAK-279 affects the body of healthy adults and processes midazolam and repaglinide (pharmacokinetics or PK). Another aim is to learn about the side effects of TAK-279 and how well it is tolerated when given to healthy adults either alone or together with midazolam or repaglinide.
During the study, participants will need to stay at the clinic for 19 days. Blood samples will be taken at several timepoints during the study. The study drug will be given by mouth (orally).
Detailed description
The drug being tested in this study is called TAK-279. The study will assess the potential effect of TAK-279 on cytochrome P450 (CYP) 3A4 using the probe substrate midazolam and the potential effect of TAK-279 on CYP2C8 using the probe substrate repaglinide in healthy participants.
The study will enroll approximately 20 participants. Participants will be enrolled in one of the four treatments.
- Treatment A: Midazolam 2 milligram (mg)
- Treatment B: Repaglinide 0.5 mg
- Treatment A + Treatment C: Midazolam 2 mg + TAK-279 Dose 1
- Treatment B + Treatment C: Repaglinide 0.5 mg + TAK-279 Dose 1
This single-center trial will be conducted in the United States. The overall study duration is approximately 59 days including screening period and follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A: Midazolam 2 mg | Experimental | Drug: MidazolamMidazolam 2 mg (1 milliliter [mL] of 2 milligram per milliliter [mg/mL]), syrup, orally, on Day 1 of Period 1. |
| Treatment B: Repaglinide 0.5 mg | Experimental | Drug: RepaglinideRepaglinide 0.5 mg (1*0.5 mg), tablets, orally, on Day 2 of Period 1. |
| Treatment C + Treatment A: TAK-279 Dose 1 + Midazolam 2 mg | Experimental | Drug: Midazolam, Drug: TAK-279TAK-279 Dose 1, capsules, orally, on Days 1 through 15 of Period 2 followed by Midazolam 2 mg (1 mL of 2 mg/mL), syrup, orally, on Day 14 of Period 2. |
| Treatment C + Treatment B: TAK-279 Dose 1 + Repaglinide 0.5 mg | Experimental | Drug: Repaglinide, Drug: TAK-279TAK-279 Dose 1, capsules, orally, on Days 1 through 15 of Period 2 followed by Repaglinide 0.5 mg (1*0.5 mg), tablets, orally, on Day 15 of Period 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Participants must fulfill all of the following inclusion criteria to be eligible for participation in the study:
- Continuous non-smoker who has not used nicotine and tobacco containing products for at least 3 months prior to the first dosing based on subject self-reporting.
- Body mass index (BMI) greater than or equal to (>=) 18.0 and less than or equal to (<=) 32.0 kilogram per square meter (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:
Key exclusion criteria (34 listed)
- Participants must not be enrolled in the study if they meet any of the following criteria:
- Fasting glucose >125 milligram per deciliter (mg/dL) at the screening visit.
- Has a history or presence 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.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs.
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 |
|---|---|---|
| MidazolamMidazolam syrup. | Drug | Treatment A: Midazolam 2 mg, Treatment C + Treatment A: TAK-279 Dose 1 + Midazolam 2 mg |
| RepaglinideRepaglinide tablets. | Drug | Treatment B: Repaglinide 0.5 mg, Treatment C + Treatment B: TAK-279 Dose 1 + Repaglinide 0.5 mg |
| TAK-279TAK-279 capsules. | Drug | Treatment C + Treatment A: TAK-279 Dose 1 + Midazolam 2 mg, Treatment C + Treatment B: TAK-279 Dose 1 + Repaglinide 0.5 mg |
Primary outcome
Cmax: Maximum Observed Plasma Concentration for Midazolam and Repaglinide When Administered Alone and With TAK-279
Time frame: Period 1-Midazolam Alone: Day 1 predose up to 24 hours (h) postdose; Repaglinide Alone: Day 2 predose up to 16 h postdose; Period 2-Midazolam, With TAK-279: Day 14 predose up to 24 h postdose; Repaglinide with TAK-279:Day 15 predose up to 16 h postdose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Midazolam and Repaglinide When Administered Alone and With TAK-279
Time frame: Period 1-Midazolam Alone: Day 1 predose up to 24 hours (h) postdose; Repaglinide Alone: Day 2 predose up to 16 h postdose; Period 2-Midazolam, With TAK-279: Day 14 predose up to 24 h postdose; Repaglinide with TAK-279:Day 15 predose up to 16 h postdose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Midazolam and Repaglinide When Administered Alone and With TAK-279
Time frame: Period 1-Midazolam Alone: Day 1 predose up to 24 hours (h) postdose; Repaglinide Alone: Day 2 predose up to 16 h postdose; Period 2-Midazolam, With TAK-279: Day 14 predose up to 24 h postdose; Repaglinide with TAK-279:Day 15 predose up to 16 h postdose
1 secondary outcome
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI)
Time frame: From Day 1 of Period 1 up to 14 days after the last dose of TAK-279 in Period 2 (up to 29 days)
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 23 May 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
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 Midazolam, Repaglinide and TAK-279 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 9 inclusion and 34 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 23 May 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?
Cmax: Maximum Observed Plasma Concentration for Midazolam and Repaglinide When Administered Alone and With TAK-279 (time frame: Period 1-Midazolam Alone: Day 1 predose up to 24 hours (h) postdose; Repaglinide Alone: Day 2 predose up to 16 h postdose; Period 2-Midazolam, With TAK-279: Day 14 predose up to 24 h postdose; Repaglinide with TAK-279:Day 15 predose up to 16 h postdose). 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 23 May 2024.