A Phase 1 interventional study of TAK-988 and TAK-988 Placebo in Healthy Volunteers, sponsored by Takeda. Withdrawn at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-26.
Sponsored by Takeda · Phase 1, Interventional, and Other
The purpose of this study is to assess the safety and tolerability of TAK-988 following single and multiple oral doses in healthy non-Japanese and Japanese adult participants and healthy elderly (HE) participants.
The drug being tested in this study is called TAK-988. TAK-988 is being tested to evaluate safety, tolerability, PK, and PD of single and multiple oral doses in healthy non-Japanese and Japanese adult participants and HE participants.
The study will enroll approximately 156 healthy participants. The study consists of 5 parts and up to 19 cohorts as mentioned below:
Participants in each cohort will be randomized to receive treatment with TAK-988 or matching placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).
This multi-center trial will be conducted in the United States. The overall duration of the study is approximately 10.5 months. Participants will make a final visit 7 days after receiving their last dose of study drug for a follow-up assessment.
Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
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)
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, and C)
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)
TAK-988 tablet or TAK-988 placebo-matching tablet, 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, PK, and PD data from previous cohorts.
Drug: TAK-988 · Drug: TAK-988 Placebo
TAK-988 tablet or TAK-988 placebo-matching tablet, orally, twice daily (6-hour interval) from Day 1 to Day 14 to healthy non-Japanese participants. Dose escalation will be based on review of the emerging safety/tolerability, PK, and PD data from previous cohorts and Part A.
Drug: TAK-988 · Drug: TAK-988 Placebo
TAK-988 tablet or TAK-988 placebo-matching tablet, orally, twice daily (6-hour interval) from Day 1 to Day 7 to healthy non-Japanese participants. Dose will be determined based on previous multiple-rising dose (MRD) cohorts.
Drug: TAK-988 · Drug: TAK-988 Placebo
TAK-988 tablet or TAK-988 placebo-matching tablet, orally, twice daily (6-hour interval) from Day 1 to Day 14 to HE non-Japanese participants. Dose will be determined based on previous MRD cohorts.
Drug: TAK-988 · Drug: TAK-988 Placebo
TAK-988 tablet or TAK-988 placebo-matching tablet, orally, once on Day 1, followed by a washout period of 2 days and twice daily (6- hour interval) on Day 3 and continue to Day 17 to healthy Japanese participants. Dose will be determined based on previous MRD cohorts.
Drug: TAK-988 · Drug: TAK-988 Placebo
TAK-988 tablets.
TAK-988 placebo-matching tablets.
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 26
Number of Participants With at Least one Markedly Abnormal Value (MAV) for Laboratory Values
Time frame: Baseline up to Day 26
Number of Participants With at Least one MAV for Vital Signs
Time frame: Baseline up to Day 26
Number of Participants With at Least one MAV for Electrocardiograms (ECGs)
Time frame: Baseline up to Day 26
Cmax: Maximum Observed Plasma Concentration for TAK-988
Time frame: Day 1 (Parts A-E), Day 7 (Part C), Day 14 (Parts B and D), Day 17 (Part E) pre-dose and at multiple time points (up to 72 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-988
Time frame: Day 1 (Parts A-E), Day 7 (Part C), Day 14 (Parts B and D), Day 17 (Part E) pre-dose and at multiple time points (up to 72 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-988
Time frame: Day 1 (Parts A-E) pre-dose and at multiple time points (up to 72 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-988
Time frame: Day 1 (Parts A-E) pre-dose and at multiple time points (up to 72 hours) post-dose
T1/2z: Terminal Disposition Phase Half-life for TAK-988
Time frame: Day 1 (Parts A-E) pre-dose and at multiple time points (up to 72 hours) post-dose
CLR: Renal Clearance for TAK-988
Time frame: Day 1 (Parts A, B, D and E), Day 14 (Parts B and D), Day 17 (Part E) pre-dose and at multiple time points (up to 72 hours) post-dose
AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to tau over Dosing Interval for TAK-988
Time frame: Day 7 (Part C), Day 14 (Parts B and D), Day 17 (Part E) pre-dose and at multiple time points (up to 72 hours) post-dose
Part C: Ratio of the Cerebrospinal Fluid (CSF) to Plasma AUC From Time 0 to 24 Hours for TAK-988
Time frame: Day 7 (Part C) Pre-dose and at multiple time points (up to 24 hours) post-dose
Rac (AUC): Accumulation Ratio Based on AUCτ for TAK-988
Time frame: Day 7 (Part C), Day 14 (Parts B and D), Day 17 (Part E) pre-dose and at multiple time points (up to 72 hours) post-dose
Plan to share: 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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This study is withdrawn, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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