Healthy VolunteersPhase 1NCT05818956
A Study of TAK-227 in Healthy Adults
A Phase 1 study testing TAK-227 in people with Healthy Volunteers, run by Takeda at 1 site in United States.
Trial summary
The main aim of this study is to test the effects of food consumption with sponsor compound TAK-227 in healthy participants. The study will also measure side effects, and to check how much TAK-227 stays in the blood over time to work out the best dose. 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-227
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2023to 26 Jun 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 the following inclusion criteria to be eligible for participation in the study:
- Body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to (<=) 32.0 kilogram per square meter (kg/m^2) at screening visit.
- 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.
Who cannot join
- Participants must not be enrolled in the study if they meet any of the following criteria:
- 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.
- Drink alcohol in excess of 21 units per week for males or 14 units per week for females, with one unit equal to (=) 150 milliliter (mL) of wine or 360 mL of beer or 45 mL of 45 percent (%) alcohol.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Unable to refrain from or anticipates the use of:
- Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing and throughout the study. Medication listed as part of acceptable birth control methods will be allowed. Thyroid hormone replacement medication may be permitted if the participant has been on the same stable dose for the immediate 3 months prior to first study drug administration. Hormone replacement therapy will also be allowed.
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- Any drugs known to be significant inducers or inhibitors of Cytochrome P450 (CYP)3A4 enzymes and/or P-glycoprotein (gp), including St. John's Wort, within 28 days prior to the first dosing and throughout the study. Appropriate sources (example, Flockhart Table TM) will be consulted to confirm lack of pharmacokinetic (PK)/pharmacodynamics interaction with study drug.
- Chronic use of non-steroidal anti-inflammatory (define as more that 7 days of use) within 2 weeks prior to screening and throughout the study.
- Donation of blood or significant blood loss within 56 days prior to the first dosing.
- Plasma donation within 7 days prior to the first dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single-dose, Three-way Crossover Evaluation of the Effect of Food on the Pharmacokinetics, Safety, and Tolerability of TAK-227 in Healthy Adult Participants
The main aim of this study is to test the effects of food consumption with sponsor compound TAK-227 in healthy participants. The study will also measure side effects, and to check how much TAK-227 stays in the blood over time to work out the best dose.
Read the detailed description
The drug being tested in this study is called TAK-227. This study will assess the effect of food on single-dose of TAK-227 in healthy participants.
The study will enroll approximately 24 participants. A single dose of 50 milligram (mg) TAK-227 will be administered orally under one of 3 different feeding conditions.
- Fasting (Treatment A),
- Fed following a high-fat or high-calorie meal prior to dosing (Treatment B), and
- Fed following a high-fat or high-calorie meal after dosing (Treatment C)
Participants will be randomly assigned to 1 of the 6 treatments sequences based on the 3 feeding conditions.
- Sequence 1: (Treatment A + Treatment B + Treatment C)
- Sequence 2: (Treatment B + Treatment C + Treatment A)
- Sequence 3: (Treatment C + Treatment A + Treatment B)
- Sequence 4: (Treatment A + Treatment C + Treatment B)
- Sequence 5: (Treatment B + Treatment A + Treatment C)
- Sequence 6: (Treatment C + Treatment B + Treatment A)
All participants will receive all 6 treatment regimens. This is a single-center trial. Participants will be followed up for up to 7 days after the last dose of study drug for a follow-up assessment. The overall time to participate in this study is approximately 40 days including screening period and follow-up period.
- Conditions
- Healthy Volunteers
- Being tested
- TAK-227
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-227Drug
TAK-227 capsules.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: (Treatment A + Treatment B + Treatment C) | Experimental | TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 under fasting condition as Treatment A, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C. There will be a washout period of at least 4 days between each dosing. Receives: Drug: TAK-227 |
| Sequence 2: (Treatment B + Treatment C + Treatment A) | Experimental | TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 under fasting condition as Treatment A . There will be a washout period of at least 4 days between each dosing. Receives: Drug: TAK-227 |
| Sequence 3: (Treatment C + Treatment A + Treatment B) | Experimental | TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 under fasting condition as Treatment A, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B. There will be a washout period of at least 4 days between each dosing. Receives: Drug: TAK-227 |
| Sequence 4: (Treatment A + Treatment C + Treatment B) | Experimental | TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 under fasting condition as Treatment A, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B. There will be a washout period of at least 4 days between each dosing. Receives: Drug: TAK-227 |
| Sequence 5: (Treatment B + Treatment A + Treatment C) | Experimental | TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 under fasting condition as Treatment A, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C. There will be a washout period of at least 4 days between each dosing. Receives: Drug: TAK-227 |
| Sequence 6: (Treatment C + Treatment B + Treatment A) | Experimental | TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 under fasting condition as Treatment A. There will be a washout period of at least 4 days between each dosing. Receives: Drug: TAK-227 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: Maximum Observed Plasma Concentration for TAK-227
Measured: Day 1 pre-dose and at multiple time points (up to 36 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-227
Measured: Day 1 pre-dose and at multiple time points (up to 36 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-227
Measured: Day 1 pre-dose and at multiple time points (up to 36 hours) post-dose
Secondary outcomes (7)
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who had signed the informed consent form (ICF) to participate in a study; it did not necessarily have to have a causal relationship with the treatment. An SAE was any untoward medical occurrence that at any dose met one or more of the following criteria: resulted in death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.
Measured: From start of study drug administration up to 7 days after the last dose (up to Day 20)
Number of Participants Based on Severity of TEAE
Severity of a TEAEs were determined by following criteria: Mild: event that did not generally interfere with usual activities of daily living; Moderate: event that interfere with usual activities of daily living, causing discomfort, permanent risk of harm; Severe: AE that interrupt usual activities of daily living, significantly affects clinical status, or might require intensive therapeutic intervention.
Measured: From start of study drug administration up to 7 days after the last dose (up to Day 20)
Number of Participants Based on Causality of TEAEs
Causality of TEAEs to the study medication was assessed using the following categories: Related: An AE that followed a reasonable temporal sequence from administration of a drug (including the course after withdrawal of the drug), or for which a causal relationship was at least a reasonable possibility, that is, the relationship cannot be ruled out, although factors other than the drug, such as underlying diseases, complications, concomitant drugs and concurrent treatments, might also be responsible; Not Related: An AE that did not follow a reasonable temporal sequence from administration of a drug and/or that can reasonably be explained by other factors, such as underlying diseases, complications, concomitant medications and concurrent treatments.
Measured: From start of study drug administration up to 7 days after the last dose (up to Day 20)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values
Vital signs included body temperature (oral or tympanic measurement), respiratory rate, blood pressure [systolic blood pressure (SBP) and diastolic blood pressure (DBP)], and pulse (beats per minute). The clinically significant change assessment was based on investigator's judgment. Number of participants with clinically significant change from baseline in vital signs values were reported.
Measured: Baseline to Day 13
Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECG) Values
ECGs was performed with participants in a supine position. All ECG tracings were reviewed by the investigator or designee. Number of participants with clinically significant change from baseline in ECG values were reported.
Measured: Baseline to Day 13
Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
The clinically significant change assessment was based on investigator's judgment. Number of participants with clinically significant change from baseline in laboratory values (hematology, serum chemistry, and urinalysis) were reported.
Measured: Baseline to Day 13
Number of Participants With Clinically Significant Change From Baseline in Physical Examination
Physical examination included the following body systems: (1) respiratory system; (2) cardiovascular system; (3) nervous system (4) dermatologic system; and (5) gastrointestinal system. The clinically significant change assessment was based on investigator's judgment. Number of participants with clinically significant change from baseline in physical examination values were reported.
Measured: Baseline to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start25 May 2023
- Primary completion19 Jun 2023
- Study completion26 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT05818956
- Sponsor's protocol ID
- TAK-227-1001
- Status last verified
- Feb 2024
- First submitted
- 6 Apr 2023
- Last updated
- 6 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Three-way Crossover Evaluation of the Effect of Food on the Pharmacokinetics, Safety, and Tolerability of TAK-227 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05818956
- Acronym / sponsor ID
- TAK-227-1001
- Conditions
- Healthy Volunteers
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 25 May 2023 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 19 Apr 2023 (actual)
- Results
- Posted 6 Aug 2024
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 test the effects of food consumption with sponsor compound TAK-227 in healthy participants. The study will also measure side effects, and to check how much TAK-227 stays in the blood over time to work out the best dose.
Detailed description
The drug being tested in this study is called TAK-227. This study will assess the effect of food on single-dose of TAK-227 in healthy participants.
The study will enroll approximately 24 participants. A single dose of 50 milligram (mg) TAK-227 will be administered orally under one of 3 different feeding conditions.
- Fasting (Treatment A),
- Fed following a high-fat or high-calorie meal prior to dosing (Treatment B), and
- Fed following a high-fat or high-calorie meal after dosing (Treatment C)
Participants will be randomly assigned to 1 of the 6 treatments sequences based on the 3 feeding conditions.
- Sequence 1: (Treatment A + Treatment B + Treatment C)
- Sequence 2: (Treatment B + Treatment C + Treatment A)
- Sequence 3: (Treatment C + Treatment A + Treatment B)
- Sequence 4: (Treatment A + Treatment C + Treatment B)
- Sequence 5: (Treatment B + Treatment A + Treatment C)
- Sequence 6: (Treatment C + Treatment B + Treatment A)
All participants will receive all 6 treatment regimens. This is a single-center trial. Participants will be followed up for up to 7 days after the last dose of study drug for a follow-up assessment. The overall time to participate in this study is approximately 40 days including screening period and follow-up period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: (Treatment A + Treatment B + Treatment C) | Experimental | Drug: TAK-227TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 under fasting condition as Treatment A, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C. There will be a washout period of at least 4 days between each dosing. |
| Sequence 2: (Treatment B + Treatment C + Treatment A) | Experimental | Drug: TAK-227TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 under fasting condition as Treatment A . There will be a washout period of at least 4 days between each dosing. |
| Sequence 3: (Treatment C + Treatment A + Treatment B) | Experimental | Drug: TAK-227TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 under fasting condition as Treatment A, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B. There will be a washout period of at least 4 days between each dosing. |
| Sequence 4: (Treatment A + Treatment C + Treatment B) | Experimental | Drug: TAK-227TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 under fasting condition as Treatment A, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B. There will be a washout period of at least 4 days between each dosing. |
| Sequence 5: (Treatment B + Treatment A + Treatment C) | Experimental | Drug: TAK-227TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 under fasting condition as Treatment A, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C. There will be a washout period of at least 4 days between each dosing. |
| Sequence 6: (Treatment C + Treatment B + Treatment A) | Experimental | Drug: TAK-227TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 under fasting condition as Treatment A. There will be a washout period of at least 4 days between each dosing. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants must fulfill the following inclusion criteria to be eligible for participation in the study:
- Body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to (<=) 32.0 kilogram per square meter (kg/m^2) at screening visit.
- 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.
Key exclusion criteria (10 listed)
- Participants must not be enrolled in the study if they meet any of the following criteria:
- 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.
- Drink alcohol in excess of 21 units per week for males or 14 units per week for females, with one unit equal to (=) 150 milliliter (mL) of wine or 360 mL of beer or 45 mL of 45 percent (%) alcohol.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Unable to refrain from or anticipates the use of:
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-227TAK-227 capsules. | Drug | Sequence 1: (Treatment A + Treatment B + Treatment C), Sequence 2: (Treatment B + Treatment C + Treatment A), Sequence 3: (Treatment C + Treatment A + Treatment B), Sequence 4: (Treatment A + Treatment C + Treatment B), Sequence 5: (Treatment B + Treatment A + Treatment C), Sequence 6: (Treatment C + Treatment B + Treatment A) |
Primary outcome
Cmax: Maximum Observed Plasma Concentration for TAK-227
Time frame: Day 1 pre-dose and at multiple time points (up to 36 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-227
Time frame: Day 1 pre-dose and at multiple time points (up to 36 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-227
Time frame: Day 1 pre-dose and at multiple time points (up to 36 hours) post-dose
7 secondary outcomes
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: From start of study drug administration up to 7 days after the last dose (up to Day 20)
Number of Participants Based on Severity of TEAE
Time frame: From start of study drug administration up to 7 days after the last dose (up to Day 20)
Number of Participants Based on Causality of TEAEs
Time frame: From start of study drug administration up to 7 days after the last dose (up to Day 20)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values
Time frame: Baseline to Day 13
Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECG) Values
Time frame: Baseline to Day 13
Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
Time frame: Baseline to Day 13
Number of Participants With Clinically Significant Change From Baseline in Physical Examination
Time frame: Baseline to Day 13
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain more information about this study, click this link.Link 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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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-227 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 3 inclusion and 10 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 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 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?
Yes. Results are posted in the registry (first posted 6 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax: Maximum Observed Plasma Concentration for TAK-227 (time frame: Day 1 pre-dose and at multiple time points (up to 36 hours) post-dose). 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 Aug 2024.