HealthyPhase 1NCT02723201
TAK-020 Relative Bioavailability and Food Effect Study in Healthy Participants
A Phase 1 study testing TAK-020 Captisol Oral Solution, TAK-020 CCT and TAK-020 SDT in people with Healthy, run by Takeda at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the relative bioavailability of solid oral formulations of TAK-020 in comparison with single dose of TAK-020 oral solution formulation and to evaluate the food effect and potentially the dose proportionality of the optimal oral solid formulation. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TAK-020 Captisol Oral Solution, TAK-020 CCT and TAK-020 SDT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Apr 2016to 24 Aug 2016
- 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
- Is capable of understanding and complying with protocol requirements.
- Is legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations.
- Is a healthy adult male or female.
- Is aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.
- Weighs at least 45 kilogram (kg) and has a body mass index (BMI) between 18 and 32 kilogram per square meter (kg/m^2), inclusive at Screening and Day -1.
- Male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 90 days after last dose of study medication.
- Female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent and throughout the duration of the study and until the next menstrual period or 90 days after exit from the study, whichever is first. If the next menstrual period is delayed, a pregnancy test will be required for exclusion of pregnancy.
Who cannot join
- Has received any investigational compound within 30 days prior to Screening.
- Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
- Has a known hypersensitivity to any component of the formulation of TAK-020, Captisol, or related compounds.
- Has a positive urine drug result for drugs of abuse or a positive breath alcohol screen at Screening or Check-in (Day -1).
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as 4 or more alcoholic units per day) within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
- Has taken any excluded medication, supplements, or food products listed in Prohibited Medications and Foods table.
Show all 22Show fewer
- If female, is pregnant or lactating or intending to become pregnant before, during or within 3 months after exit from this study (90 days post last dose); or intending to donate ova during such time period.
- If male, the participant intends to donate sperm during the course of this study or for 90 days after the last dose of study drug.
- Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash.
- Has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (that is, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention [example, cholecystectomy]).
- Has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.
- Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in Day -1. Cotinine test is positive at Screening or Check-in (Day -1).
- Has poor peripheral venous access.
- Has donated or lost 450 mililiter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day 1.
- Has a Screening or Check-in (Day -1) abnormal (clinically significant) ECG. Entry of any participant with an abnormal (not clinically significant) ECG must be approved, and documented by signature by the principal investigator or medically qualified subinvestigator.
- Has QT interval with Fridericia correction method (QTcF) greater than (>) 430 millisecond (msec) for men and >450 msec for women or PR outside the range of 120 to 220 msec confirmed upon repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in (Day -1).
- Has abnormal Screening or Day -1 laboratory values that suggest a clinically significant underlying disease or participant with the following lab abnormalities:
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.2* the upper limit of normal (ULN).
- Positive screen test for drugs of abuse.
- Positive blood screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus-1 or -2 antibodies (test done at Screening visit only).
- A positive test for tuberculosis (TB) (QuantiFERON) (test done at Screening Visit only).
- Vaccination with any live vaccine within 4 weeks of study drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label Phase 1 Study in Healthy Volunteers to Evaluate the Relative Bioavailability of a Single Dose of Various Test Solid Formulations of TAK-020 Compared With a Single Dose of Reference Oral Solution and to Evaluate the Food Effect and Potentially the Dose Proportionality of the Optimal Solid Dose Formulation
The purpose of this study is to assess the relative bioavailability of solid oral formulations of TAK-020 in comparison with single dose of TAK-020 oral solution formulation and to evaluate the food effect and potentially the dose proportionality of the optimal oral solid formulation.
Read the detailed description
TAK-020 is being developed for the potential treatment of autoimmune diseases including rheumatoid arthritis. Currently TAK-020 is available as an oral solution. This study is to develop an oral tablet formulation. There are three parts to this study. Part 1 will compare different tablet formulations of TAK-020 compared to a reference oral solution to identify the best tablet formulation to use in Parts 2 and 3. Part 2 will look at the effect food has on TAK-020. Part 3 is optional; its implementation will be decided upon using data from Part 2. It will evaluate whether increased doses of TAK-020 produce an expected proportional increase in the plasma concentration of TAK-020.
In Part 1 participants will receive a single dose of the following:
Period 1: TAK-020 Oral Solution Period 2: TAK-020 Co-Crystal Tablet Period 3: TAK-020 Solid Dispersion Tablet Period 4: TAK-020 Immediate Release Tablet
In Part 2 participants will be split into two groups; one will receive the chosen formulation of TAK-020 in the fasted state followed by the fed state and the other group will receive it in the fed state followed by the fasted state. The dose used in Part 2 will be based upon data from Part 1 and previous studies.
Participants in Part 3 of the study will be split into 2 cohorts. Each cohort will be administered, in the fasted state, a single dose of the tablet selected as optimal from previous study parts. The dose used will be based upon data from Parts 1 and 2 and previous studies.
Part 1 will assess the relative bioavailability of TAK-020 by using analysis of variance (ANOVA) on tmax, and the natural logarithms of AUCs, and Cmax. Part 2 will assess the food effect of TAK-020, also using ANOVA on tmax, and the natural logarithms of AUCs, and Cmax. The power model will be used to assess dose proportionality of single doses of the solid formulations in the fasted state from Parts 2 and 3.
- Conditions
- Healthy
- Being tested
- TAK-020 Captisol Oral Solution, TAK-020 CCT, TAK-020 SDT, TAK-020 IRT, TAK-020 Solid Formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-020 Captisol Oral SolutionDrug
TAK-020 solution.
TAK-020 CCTDrug
TAK-020 co-crystal tablet
TAK-020 SDTDrug
TAK-020 Solid dispersion tablet.
TAK-020 IRTDrug
TAK-020 immediate release tablet.
TAK-020 CCTDrug
TAK-020 co-crystal tablet.
TAK-020 Solid FormulationDrug
TAK-020 solid formulation
| Study group | Role | What they receive |
|---|---|---|
| Part-1, Period 1: TAK-020 17.5 mg Oral Solution | Experimental | Single dose 17.5 milligram (mg), on Day 1, followed by 7 days of washout. Dose will be determined from TAK-020 single rising dose (SRD) trial. Receives: Drug: TAK-020 Captisol Oral Solution |
| Part-1, Period 2: TAK-020 17.5 mg Co-crystal Tablet (CCT) | Experimental | Single oral dose 17.5 mg, on Day 1, followed by 7 days of washout. Dose will be the same as Part 1, Period 1. Receives: Drug: TAK-020 CCT |
| Part-1, Period 3:TAK-020 17.5 mg Solid Dispersion Tablet (SDT) | Experimental | Single oral dose 17.5 mg, on Day 1, followed by 7 days of washout. Dose will be the same as Part 1, Period 1. Receives: Drug: TAK-020 SDT |
| Part-1, Period 4:TAK-020 17.5 mg Immediate Release Tablet(IRT) | Experimental | Single oral dose 17.5 mg, on Day 1, followed by 7 days of washout. Dose will be the same as Part 1, Period 1. Receives: Drug: TAK-020 IRT |
| Part 2, Period 1: TAK-020 25 mg CCT | Experimental | Participants will be randomized to AB or BA crossover where A= Fasted, B =Fed. Sequence I: Single oral dose TAK-020 25 mg, Fasted (A), 7 days washout, single oral dose TAK-020 Fed (B) Sequence II: Single oral dose TAK-020 25 mg, Fed (B), 7 days washout, single oral dose TAK-020 Fasted (A) Dose will be determined from SRD trial and Part 1. Receives: Drug: TAK-020 CCT |
| Part- 3 Cohort 1: TAK-020 Solid Formulation | Experimental | Single oral dose on Day 1. Dose will be determined from SRD trial and Parts 1 and 2 Receives: Drug: TAK-020 Solid Formulation |
| Part 3 Cohort 2: TAK-020 Solid Formulation | Experimental | Single oral dose on Day 1. Dose will be determined from SRD trial and Parts 1 and 2 Receives: Drug: TAK-020 Solid Formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: Maximum Observed Plasma Concentration for TAK-020
Measured: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020
Measured: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-020
Measured: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Terminal Disposition Phase Half-life (T1/2z) in Plasma for TAK-020
Measured: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Secondary outcomes (4)
Number of Participants Who Experience at Least One or More Treatment-emergent Adverse Event (TEAE)
Measured: Baseline up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post Dose
Measured: Baseline up to Day 2
Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Measured: Baseline up to Day 2
Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose
Measured: Baseline up to Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study start28 Apr 2016
- Primary completion5 Aug 2016
- Study completion24 Aug 2016
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 HealthyStudies 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
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723201
- Sponsor's protocol ID
- TAK-020-1002
- Other IDs
- U1111-1171-4650, 2015-002635-18, 16/WA/0012, 2015
- Status last verified
- Apr 2018
- First submitted
- 24 Mar 2016
- Last updated
- 13 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label Phase 1 Study in Healthy Volunteers to Evaluate the Relative Bioavailability of a Single Dose of Various Test Solid Formulations of TAK-020 Compared With a Single Dose of Reference Oral Solution and to Evaluate the Food Effect and Potentially the Dose Proportionality of the Optimal Solid Dose Formulation
- ClinicalTrials.gov ID
- NCT02723201
- Acronym / sponsor ID
- TAK-020-1002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2016
- Primary completion
- 5 Aug 2016 (actual)
- Study completion
- 24 Aug 2016 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Posted 13 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the relative bioavailability of solid oral formulations of TAK-020 in comparison with single dose of TAK-020 oral solution formulation and to evaluate the food effect and potentially the dose proportionality of the optimal oral solid formulation.
Detailed description
TAK-020 is being developed for the potential treatment of autoimmune diseases including rheumatoid arthritis. Currently TAK-020 is available as an oral solution. This study is to develop an oral tablet formulation. There are three parts to this study. Part 1 will compare different tablet formulations of TAK-020 compared to a reference oral solution to identify the best tablet formulation to use in Parts 2 and 3. Part 2 will look at the effect food has on TAK-020. Part 3 is optional; its implementation will be decided upon using data from Part 2. It will evaluate whether increased doses of TAK-020 produce an expected proportional increase in the plasma concentration of TAK-020.
In Part 1 participants will receive a single dose of the following:
Period 1: TAK-020 Oral Solution Period 2: TAK-020 Co-Crystal Tablet Period 3: TAK-020 Solid Dispersion Tablet Period 4: TAK-020 Immediate Release Tablet
In Part 2 participants will be split into two groups; one will receive the chosen formulation of TAK-020 in the fasted state followed by the fed state and the other group will receive it in the fed state followed by the fasted state. The dose used in Part 2 will be based upon data from Part 1 and previous studies.
Participants in Part 3 of the study will be split into 2 cohorts. Each cohort will be administered, in the fasted state, a single dose of the tablet selected as optimal from previous study parts. The dose used will be based upon data from Parts 1 and 2 and previous studies.
Part 1 will assess the relative bioavailability of TAK-020 by using analysis of variance (ANOVA) on tmax, and the natural logarithms of AUCs, and Cmax. Part 2 will assess the food effect of TAK-020, also using ANOVA on tmax, and the natural logarithms of AUCs, and Cmax. The power model will be used to assess dose proportionality of single doses of the solid formulations in the fasted state from Parts 2 and 3.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part-1, Period 1: TAK-020 17.5 mg Oral Solution | Experimental | Drug: TAK-020 Captisol Oral SolutionSingle dose 17.5 milligram (mg), on Day 1, followed by 7 days of washout. Dose will be determined from TAK-020 single rising dose (SRD) trial. |
| Part-1, Period 2: TAK-020 17.5 mg Co-crystal Tablet (CCT) | Experimental | Drug: TAK-020 CCTSingle oral dose 17.5 mg, on Day 1, followed by 7 days of washout. Dose will be the same as Part 1, Period 1. |
| Part-1, Period 3:TAK-020 17.5 mg Solid Dispersion Tablet (SDT) | Experimental | Drug: TAK-020 SDTSingle oral dose 17.5 mg, on Day 1, followed by 7 days of washout. Dose will be the same as Part 1, Period 1. |
| Part-1, Period 4:TAK-020 17.5 mg Immediate Release Tablet(IRT) | Experimental | Drug: TAK-020 IRTSingle oral dose 17.5 mg, on Day 1, followed by 7 days of washout. Dose will be the same as Part 1, Period 1. |
| Part 2, Period 1: TAK-020 25 mg CCT | Experimental | Drug: TAK-020 CCTParticipants will be randomized to AB or BA crossover where A= Fasted, B =Fed. Sequence I: Single oral dose TAK-020 25 mg, Fasted (A), 7 days washout, single oral dose TAK-020 Fed (B) Sequence II: Single oral dose TAK-020 25 mg, Fed (B), 7 days washout, single oral dose TAK-020 Fasted (A) Dose will be determined from SRD trial and Part 1. |
| Part- 3 Cohort 1: TAK-020 Solid Formulation | Experimental | Drug: TAK-020 Solid FormulationSingle oral dose on Day 1. Dose will be determined from SRD trial and Parts 1 and 2 |
| Part 3 Cohort 2: TAK-020 Solid Formulation | Experimental | Drug: TAK-020 Solid FormulationSingle oral dose on Day 1. Dose will be determined from SRD trial and Parts 1 and 2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Is capable of understanding and complying with protocol requirements.
- Is legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations.
- Is a healthy adult male or female.
- Is aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.
- Weighs at least 45 kilogram (kg) and has a body mass index (BMI) between 18 and 32 kilogram per square meter (kg/m^2), inclusive at Screening and Day -1.
Key exclusion criteria (22 listed)
- Has received any investigational compound within 30 days prior to Screening.
- Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
- Has a known hypersensitivity to any component of the formulation of TAK-020, Captisol, or related compounds.
- Has a positive urine drug result for drugs of abuse or a positive breath alcohol screen at Screening or Check-in (Day -1).
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as 4 or more alcoholic units per day) within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
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-020 Captisol Oral SolutionTAK-020 solution. | Drug | Part-1, Period 1: TAK-020 17.5 mg Oral Solution |
| TAK-020 CCTTAK-020 co-crystal tablet | Drug | Part-1, Period 2: TAK-020 17.5 mg Co-crystal Tablet (CCT) |
| TAK-020 SDTTAK-020 Solid dispersion tablet. | Drug | Part-1, Period 3:TAK-020 17.5 mg Solid Dispersion Tablet (SDT) |
| TAK-020 IRTTAK-020 immediate release tablet. | Drug | Part-1, Period 4:TAK-020 17.5 mg Immediate Release Tablet(IRT) |
| TAK-020 CCTTAK-020 co-crystal tablet. | Drug | Part 2, Period 1: TAK-020 25 mg CCT |
| TAK-020 Solid FormulationTAK-020 solid formulation | Drug | Part 3 Cohort 2: TAK-020 Solid Formulation, Part- 3 Cohort 1: TAK-020 Solid Formulation |
Primary outcome
Cmax: Maximum Observed Plasma Concentration for TAK-020
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-020
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Terminal Disposition Phase Half-life (T1/2z) in Plasma for TAK-020
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
4 secondary outcomes
Number of Participants Who Experience at Least One or More Treatment-emergent Adverse Event (TEAE)
Time frame: Baseline up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post Dose
Time frame: Baseline up to Day 2
Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Time frame: Baseline up to Day 2
Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose
Time frame: Baseline up to Day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical 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-020 Captisol Oral Solution, TAK-020 CCT and TAK-020 SDT in people with Healthy, run by Takeda at 1 site in United Kingdom.
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 7 inclusion and 22 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 13 Apr 2018. 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 Kingdom. 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 13 Apr 2018). 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-020 (time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose). The study lists 4 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 13 Apr 2018.