| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy Participants | Drug: TAK-994 Drug: TAK-994 Placebo | Phase 1 |
The drug being tested in this study is called TAK-994. TAK-994 is being tested to find a safe and well-tolerated dose in healthy participants (non-Japanese and Japanese) and healthy elderly participants. The study will enroll up to approximately 160 healthy participants. The study consists of 6 parts and up to 20 cohorts as mentioned below.
Participants in each cohort will be randomized to receive treatment with TAK-994 or matching placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). Participants in optional Part F will receive no study drug.
This multi-center trial will be conducted in the United States. The overall duration of the study is approximately 10 months. Participants will be followed up for 7 days after the last dose of study drug for a follow-up assessment.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 121 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Other |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Healthy Subjects |
| Actual Study Start Date : | May 1, 2019 |
| Actual Primary Completion Date : | March 29, 2020 |
| Actual Study Completion Date : | March 29, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: TAK-994: Part A
TAK-994 tablet or matching placebo, orally, once on Day 1 to healthy non-Japanese participants. Sentinel dosing will be done in the first 2 cohorts of Part A (Cohorts A1 and A2 [fasted and fed dosing conditions]). Dose escalation in Cohorts A2 to A6 will be based on emerging safety, tolerability, and PK (pharmacokinetic) data from previous cohorts.
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Drug: TAK-994
TAK-994 tablets.
Drug: TAK-994 Placebo TAK-994 placebo-matching tablets.
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Experimental: TAK-994: Part B
TAK-994 tablet or matching placebo, orally, once daily or twice daily from Day 1 to Day 14 to healthy non-Japanese participants. Dose escalation will be based on review of the emerging safety, PK, and PD (pharmacodynamic) data from Part A. Fixed-dose titration regimens may also be evaluated based on review of the emerging safety, PK, and tolerability data from previous cohorts.
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Drug: TAK-994
TAK-994 tablets.
Drug: TAK-994 Placebo TAK-994 placebo-matching tablets.
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Experimental: TAK-994: Part C
TAK-994 tablet or matching placebo, orally, once daily or twice daily from Day 1 to Day 7 to healthy non-Japanese participants. Dose will be determined based on previous multiple-rising dose (MRD) cohorts.
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Drug: TAK-994
TAK-994 tablets.
Drug: TAK-994 Placebo TAK-994 placebo-matching tablets.
|
|
Experimental: TAK-994: Part D
TAK-994 tablet or matching placebo, orally, once daily or twice daily from Day 1 to Day 14 to healthy non-Japanese elderly participants. Dose will be determined based on previous MRD cohorts. Fixed-dose titration regimens may also be evaluated based on review of the emerging safety, PK, and tolerability data from previous cohorts.
|
Drug: TAK-994
TAK-994 tablets.
Drug: TAK-994 Placebo TAK-994 placebo-matching tablets.
|
|
Experimental: TAK-994: Part E
TAK-994 tablet or matching placebo, orally, once or twice on Day 1, followed by a washout period of 2 days and on Day 4 and continue to Day 17 to healthy Japanese participants. Dose will be determined based on previous MRD cohorts. Fixed-dose titration regimens may also be evaluated based on review of the emerging safety, PK, and tolerability data from previous cohorts.
|
Drug: TAK-994
TAK-994 tablets.
Drug: TAK-994 Placebo TAK-994 placebo-matching tablets.
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Be normotensive, with no history of hypertension or use of antihypertensive medication. Blood pressure (BP) must be less than (<) 140 millimeter of mercury (mmHg) (systolic) and <90 mmHg (diastolic).
Healthy Adult and Elderly Participants (Parts A through D and Part F)
Must have a body mass index (BMI) greater than or equal to (>=) 18.0 and less than or equal to (<=) 30.0 kilogram per square meter (kg/m^2) at the screening visit (non-Japanese only).
Healthy Adult Participants (Parts A, B, C, and F)
Must have a body weight >=50 kilogram (kg) at the screening visit.
HE Participants (Part D)
Must have a body weight >=40 kg at the screening visit.
Healthy Japanese Adult Participants (Part E)
Exclusion Criteria:
Has a resting heart rate outside of the range of 45 to 100 beats per minute, confirmed on repeat testing within a maximum of 30 minutes).
Healthy Non-Japanese Adult Participants (Part C and Part F)
| United States, California | |
| Parexel International | |
| Glendale, California, United States, 91206 | |
| United States, Utah | |
| PRA Health Sciences | |
| Salt Lake City, Utah, United States, 84125 | |
| Study Director: | Medical Director | Takeda |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 29, 2019 | ||||
| First Posted Date ICMJE | May 1, 2019 | ||||
| Last Update Posted Date | June 24, 2020 | ||||
| Actual Study Start Date ICMJE | May 1, 2019 | ||||
| Actual Primary Completion Date | March 29, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Healthy Participants | ||||
| Official Title ICMJE | A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Healthy Subjects | ||||
| Brief Summary | The purpose of this study is to assess the safety and tolerability of TAK-994 following single and multiple oral doses in healthy non-Japanese and Japanese adult participants and healthy elderly participants. | ||||
| Detailed Description |
The drug being tested in this study is called TAK-994. TAK-994 is being tested to find a safe and well-tolerated dose in healthy participants (non-Japanese and Japanese) and healthy elderly participants. The study will enroll up to approximately 160 healthy participants. The study consists of 6 parts and up to 20 cohorts as mentioned below.
Participants in each cohort will be randomized to receive treatment with TAK-994 or matching placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). Participants in optional Part F will receive no study drug. This multi-center trial will be conducted in the United States. The overall duration of the study is approximately 10 months. Participants will be followed up for 7 days after the last dose of study drug for a follow-up assessment. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: Double (Participant, Investigator) Primary Purpose: Other |
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| Condition ICMJE | Healthy Participants | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
121 | ||||
| Original Estimated Enrollment ICMJE |
152 | ||||
| Actual Study Completion Date ICMJE | March 29, 2020 | ||||
| Actual Primary Completion Date | March 29, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03933488 | ||||
| Other Study ID Numbers ICMJE | TAK-994-1001 U1111-1230-8479 ( Other Identifier: WHO ) |
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| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Takeda | ||||
| Study Sponsor ICMJE | Takeda | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Takeda | ||||
| Verification Date | June 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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