Healthy VolunteersPhase 1NCT03482453
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-788 Followed by Evaluation of the Effects of a Low-Fat Meal on TAK-788 PK and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Participants
A Phase 1 study testing TAK-788 in people with Healthy Volunteers, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety, tolerability of TAK-788 and to identify a tolerable single oral dose of TAK-788 administered as a drug-in-capsule (DiC) formulation, to characterize the effects of a low-fat meal on the PK of the TAK-788 administered as DiC formulation and to evaluate the… 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-788
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2018to 18 Jan 2019
- 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
- Body weight of greater than or equal to (>=) 45 kilogram (kg) (women) or >=55 kg (men) and a body mass index of 18.0 to 30.0 kilogram per square meter (kg/m^2) at screening.
- Nonsmoker (never smoked or greater than [>] 20 years from last occurrence of smoking).
- Normal organ function including hepatic, renal, and bone marrow function.
Who cannot join
- Manifestations of malabsorption due to prior gastro-intestinal (GI) surgery, GI disease, or for an unknown other reason that may alter the PK of TAK-788.
- Pulmonary infection ongoing or within 30 days of informed consent.
- Inability to undergo venipuncture and/or tolerate venous access.
- Inability to tolerate multiple blood sampling.
- Ongoing or active infection, including but not limited to, the requirement for intravenous (IV) antibiotics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Randomized, Double-blind, Placebo-Controlled, Single Rising Dose Study to Evaluate Pharmacokinetics, Safety, and Tolerability of TAK-788 Followed by Open-Label, Crossover Evaluation of the Effects of a Low-Fat Meal on TAK-788 Pharmacokinetics and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Subjects
The purpose of this study is to assess the safety, tolerability of TAK-788 and to identify a tolerable single oral dose of TAK-788 administered as a drug-in-capsule (DiC) formulation, to characterize the effects of a low-fat meal on the PK of the TAK-788 administered as DiC formulation and to evaluate the bioavailability of a test (Process B) DiC of TAK-788 relative to a reference (Process A) DiC of TAK-788 in healthy participants.
Read the detailed description
The drug being tested in this study is called TAK-788. The study will assess the safety and tolerability of single oral dose of TAK-788, evaluate the effect of a low-fat meal on PK of TAK-788 and will assess the relative bioavailability of two DiCs of TAK-788.
The study will enroll approximately 69 participants. The study is designed to consist of 3 parts: Part 1- dose escalation phase, Part 2- low fat meal effect and Part 3 - relative bioavailability. The study population of Part 1 will consist of 40 participants enrolled into 5 cohorts. Each cohort will have 8 randomized participants with 6 receiving a single dose of TAK-788, and 2 receiving matching placebo under fasted conditions. In Cohorts 1 to 5, safety of single-dose TAK-788 will be evaluated. For Part 2, the effect of a low-fat meal on a single tolerable dose of TAK-788 will be determined following review of safety and tolerability data from the previous cohorts in Part 1. The study population of Part 2 will consist of 16 participants enrolled into 2 cohorts of different doses, where participants will be randomized to a cross-over sequence of:
- TAK-788 Fed + TAK-788 Fasted
- TAK-788 Fasted + TAK-788 Fed
The study population of Part 3 will consist of 13 participants enrolled into 1 cohort, where participants will be randomized to a cross-over sequence of:
- TAK-788 DiC (reference) + TAK-788 DiC (test)
- TAK-788 DiC (test) + TAK-788 DiC (reference) This single-center trial will be conducted in the United States. The overall time to participate in this study is approximately 7 months. Participants will be contacted by telephone 30 days after the last dose of study drug for a follow-up assessment.
- Conditions
- Healthy Volunteers
- Being tested
- TAK-788, Placebo
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-788Drug
Also called AP32788
TAK-788 capsules.
PlaceboDrug
TAK-788 placebo-matching capsules.
TAK-788Drug
Also called AP32788
TAK-788 DiC.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Cohort 1: TAK-788 | Experimental | TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1. Receives: Drug: TAK-788; Drug: Placebo |
| Part 1 Cohort 2: TAK-788 | Experimental | TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 1. Receives: Drug: TAK-788; Drug: Placebo |
| Part 1 Cohort 3: TAK-788 | Experimental | TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 2. Receives: Drug: TAK-788; Drug: Placebo |
| Part 1 Cohort 4: TAK-788 | Experimental | TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 3. Receives: Drug: TAK-788; Drug: Placebo |
| Part 1 Cohort 5: TAK-788 | Experimental | TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 4. Receives: Drug: TAK-788; Drug: Placebo |
| Part 2: TAK-788 Fed + TAK-788 Fasted | Experimental | TAK-788, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A), followed by at least 7 days washout period, further followed by TAK-788, capsule, orally, once on Day 1 of Intervention Period 2 under fasted conditions (Treatment B). TAK-788 dose will be determined based on review of safety and tolerability data from cohorts of Part 1. Receives: Drug: TAK-788 |
| Part 2: TAK-788 Fasted + TAK-788 Fed | Experimental | TAK-788, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B), followed by at least 7 days washout period, further followed by TAK-788, capsule, orally, once on Day 1 of Intervention Period 2 under fed conditions with low-fat meal (Treatment A). TAK-788 dose will be determined based on review of safety and tolerability data from cohorts of Part 1. Receives: Drug: TAK-788 |
| Part 3: TAK-788 DiC (reference) + TAK-788 DiC (test) | Experimental | TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of Intervention Period 2. Receives: Drug: TAK-788 |
| Part 3: TAK-788 DiC (test) + TAK-788 DiC (reference) | Experimental | TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 2. Receives: Drug: TAK-788 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Measured: Baseline up to 30 days after the last dose of study drug (Day 31)
Part 1: Number of Participants With One or More Serious Adverse Events (SAEs)
Measured: Baseline up to 30 days after the last dose of study drug (Day 31)
Part 1: Number of Participants With Clinically Significant Abnormal Laboratory Values
Measured: Baseline up to 30 days after the last dose of study drug (Day 31)
Part 1: Number of Participants With Clinically Significant Abnormal Vital Signs
Measured: Baseline up to 30 days after the last dose of study drug (Day 31)
Part 2, Cmax: Maximum Observed Plasma Concentration for TAK-788
Measured: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 3, Cmax: Maximum Observed Plasma Concentration for TAK-788
Measured: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788
Measured: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 3, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788
Measured: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Part 2, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788
Measured: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 3, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788
Measured: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788
Measured: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 3, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788
Measured: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Part 2, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788
Measured: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 3, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788
Measured: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Secondary outcomes (9)
Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-788 and Its Active Metabolites AP32960 and AP32914
Measured: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788 and Its Active Metabolites AP32960 and AP32914
Measured: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 1, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788 and Its Active Metabolites, AP32960 and AP32914
Measured: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788 and Its Active Metabolites AP32960 and AP32914
Measured: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 1, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788 and Its Active Metabolites AP32960 and AP32914
Measured: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Parts 2 and 3: Number of Participants Reporting One or More TEAEs
Measured: Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)
Parts 2 and 3: Number of Participants With One or More SAEs
Measured: Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)
Parts 2 and 3: Number of Participants With Clinically Significant Abnormal Laboratory Values
Measured: Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)
Parts 2 and 3: Number of Participants With Clinically Significant Abnormal Vital Signs
Measured: Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start28 Mar 2018
- Primary completion22 Dec 2018
- Study completion18 Jan 2019
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.
- 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Millennium Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482453
- Sponsor's protocol ID
- TAK-788-1001
- Other IDs
- U1111-1208-9582
- Status last verified
- Jan 2020
- First submitted
- 23 Mar 2018
- Last updated
- 29 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Randomized, Double-blind, Placebo-Controlled, Single Rising Dose Study to Evaluate Pharmacokinetics, Safety, and Tolerability of TAK-788 Followed by Open-Label, Crossover Evaluation of the Effects of a Low-Fat Meal on TAK-788 Pharmacokinetics and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03482453
- Acronym / sponsor ID
- TAK-788-1001
- Conditions
- Healthy Volunteers
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 22 Dec 2018 (actual)
- Study completion
- 18 Jan 2019 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Posted 29 Jan 2020
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 safety, tolerability of TAK-788 and to identify a tolerable single oral dose of TAK-788 administered as a drug-in-capsule (DiC) formulation, to characterize the effects of a low-fat meal on the PK of the TAK-788 administered as DiC formulation and to evaluate the bioavailability of a test (Process B) DiC of TAK-788 relative to a reference (Process A) DiC of TAK-788 in healthy participants.
Detailed description
The drug being tested in this study is called TAK-788. The study will assess the safety and tolerability of single oral dose of TAK-788, evaluate the effect of a low-fat meal on PK of TAK-788 and will assess the relative bioavailability of two DiCs of TAK-788.
The study will enroll approximately 69 participants. The study is designed to consist of 3 parts: Part 1- dose escalation phase, Part 2- low fat meal effect and Part 3 - relative bioavailability. The study population of Part 1 will consist of 40 participants enrolled into 5 cohorts. Each cohort will have 8 randomized participants with 6 receiving a single dose of TAK-788, and 2 receiving matching placebo under fasted conditions. In Cohorts 1 to 5, safety of single-dose TAK-788 will be evaluated. For Part 2, the effect of a low-fat meal on a single tolerable dose of TAK-788 will be determined following review of safety and tolerability data from the previous cohorts in Part 1. The study population of Part 2 will consist of 16 participants enrolled into 2 cohorts of different doses, where participants will be randomized to a cross-over sequence of:
- TAK-788 Fed + TAK-788 Fasted
- TAK-788 Fasted + TAK-788 Fed
The study population of Part 3 will consist of 13 participants enrolled into 1 cohort, where participants will be randomized to a cross-over sequence of:
- TAK-788 DiC (reference) + TAK-788 DiC (test)
- TAK-788 DiC (test) + TAK-788 DiC (reference) This single-center trial will be conducted in the United States. The overall time to participate in this study is approximately 7 months. Participants will be contacted by telephone 30 days after the last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part 1 Cohort 1: TAK-788 | Experimental | Drug: TAK-788, Drug: PlaceboTAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1. |
| Part 1 Cohort 2: TAK-788 | Experimental | Drug: TAK-788, Drug: PlaceboTAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 1. |
| Part 1 Cohort 3: TAK-788 | Experimental | Drug: TAK-788, Drug: PlaceboTAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 2. |
| Part 1 Cohort 4: TAK-788 | Experimental | Drug: TAK-788, Drug: PlaceboTAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 3. |
| Part 1 Cohort 5: TAK-788 | Experimental | Drug: TAK-788, Drug: PlaceboTAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 4. |
| Part 2: TAK-788 Fed + TAK-788 Fasted | Experimental | Drug: TAK-788TAK-788, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A), followed by at least 7 days washout period, further followed by TAK-788, capsule, orally, once on Day 1 of Intervention Period 2 under fasted conditions (Treatment B). TAK-788 dose will be determined based on review of safety and tolerability data from cohorts of Part 1. |
| Part 2: TAK-788 Fasted + TAK-788 Fed | Experimental | Drug: TAK-788TAK-788, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B), followed by at least 7 days washout period, further followed by TAK-788, capsule, orally, once on Day 1 of Intervention Period 2 under fed conditions with low-fat meal (Treatment A). TAK-788 dose will be determined based on review of safety and tolerability data from cohorts of Part 1. |
| Part 3: TAK-788 DiC (reference) + TAK-788 DiC (test) | Experimental | Drug: TAK-788TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of Intervention Period 2. |
| Part 3: TAK-788 DiC (test) + TAK-788 DiC (reference) | Experimental | Drug: TAK-788TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body weight of greater than or equal to (>=) 45 kilogram (kg) (women) or >=55 kg (men) and a body mass index of 18.0 to 30.0 kilogram per square meter (kg/m^2) at screening.
- Nonsmoker (never smoked or greater than [>] 20 years from last occurrence of smoking).
- Normal organ function including hepatic, renal, and bone marrow function.
Key exclusion criteria (5 listed)
- Manifestations of malabsorption due to prior gastro-intestinal (GI) surgery, GI disease, or for an unknown other reason that may alter the PK of TAK-788.
- Pulmonary infection ongoing or within 30 days of informed consent.
- Inability to undergo venipuncture and/or tolerate venous access.
- Inability to tolerate multiple blood sampling.
- Ongoing or active infection, including but not limited to, the requirement for intravenous (IV) antibiotics.
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-788Also: AP32788TAK-788 capsules. | Drug | Part 1 Cohort 1: TAK-788, Part 1 Cohort 2: TAK-788, Part 1 Cohort 3: TAK-788, Part 1 Cohort 4: TAK-788, Part 1 Cohort 5: TAK-788, Part 2: TAK-788 Fasted + TAK-788 Fed, Part 2: TAK-788 Fed + TAK-788 Fasted |
| PlaceboTAK-788 placebo-matching capsules. | Drug | Part 1 Cohort 1: TAK-788, Part 1 Cohort 2: TAK-788, Part 1 Cohort 3: TAK-788, Part 1 Cohort 4: TAK-788, Part 1 Cohort 5: TAK-788 |
| TAK-788Also: AP32788TAK-788 DiC. | Drug | Part 3: TAK-788 DiC (reference) + TAK-788 DiC (test), Part 3: TAK-788 DiC (test) + TAK-788 DiC (reference) |
Primary outcome
Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to 30 days after the last dose of study drug (Day 31)
Part 1: Number of Participants With One or More Serious Adverse Events (SAEs)
Time frame: Baseline up to 30 days after the last dose of study drug (Day 31)
Part 1: Number of Participants With Clinically Significant Abnormal Laboratory Values
Time frame: Baseline up to 30 days after the last dose of study drug (Day 31)
Part 1: Number of Participants With Clinically Significant Abnormal Vital Signs
Time frame: Baseline up to 30 days after the last dose of study drug (Day 31)
Part 2, Cmax: Maximum Observed Plasma Concentration for TAK-788
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 3, Cmax: Maximum Observed Plasma Concentration for TAK-788
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 3, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Part 2, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 3, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 3, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Part 2, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 3, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
9 secondary outcomes
Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-788 and Its Active Metabolites AP32960 and AP32914
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788 and Its Active Metabolites AP32960 and AP32914
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 1, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788 and Its Active Metabolites, AP32960 and AP32914
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788 and Its Active Metabolites AP32960 and AP32914
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 1, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788 and Its Active Metabolites AP32960 and AP32914
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Parts 2 and 3: Number of Participants Reporting One or More TEAEs
Time frame: Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)
Parts 2 and 3: Number of Participants With One or More SAEs
Time frame: Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)
Parts 2 and 3: Number of Participants With Clinically Significant Abnormal Laboratory Values
Time frame: Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)
Parts 2 and 3: Number of Participants With Clinically Significant Abnormal Vital Signs
Time frame: Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Healthy Participants
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
Millennium Pharmaceuticals, Inc.
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-788 in people with Healthy Volunteers, run by Millennium Pharmaceuticals, Inc. 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 5 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 29 Jan 2020. 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 29 Jan 2020). 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?
Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) (time frame: Baseline up to 30 days after the last dose of study drug (Day 31)). The study lists 14 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 29 Jan 2020.