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TAK-071

Phase 2

Parkinson Disease | Small molecule | Neurology |Takeda Pharmaceutical Company Limited|Trials Updated: May 14, 2024

TAK-071 development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since May 2016

TAK-071 target and mechanism

Molecular targetCHRM1
Target classPositive Allosteric Modulator
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

TAK-071 clinical trials

TAK-071 · 1 trial · 2 indications

Phase 2 1
NCT04334317A Study of TAK-071 in People With Parkinson DiseaseParkinson Disease
COMPLETED64 Analytics
PHASE2COMPLETED
A Study of TAK-071 in People With Parkinson Disease
Parkinson DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Main Cohort: Change From Baseline in Stride Time (Gait) Variability During a 2-minute Dual-Task Walking Test After 6-week Treatment With TAK-071 Compared With Placebo
Baseline and Week 6 (for each study period)

Stride time (or gait) is defined as the time elapsed between the first contact of two consecutive footsteps of the same foot and is expressed in seconds. The standard deviation (SD) of the stride time, recorded for each foot during the 2-minutes, is averaged to obtain stride time (gait) variability. The 2-minute walk was performed with and without simultaneous performance of serial 3 subtraction, which adds a cognitive load to the task. Data are reported with and without cognitive load.

Sentinel Cohort, Cmax: Maximum Observed Plasma Concentration for TAK-071 in Healthy Participants
Day 1: pre-dose and Day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours)
Sentinel Cohort, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-071 in Healthy Participants
Day 1: pre-dose and Day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours)
Sentinel Cohort, AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours for TAK-071 in Healthy Participants
Day 1: Predose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours post dose
Sentinel Cohort, AUClast: Area Under The Concentration-Time Curve From Time 0 To The Last Quantifiable Concentration in Healthy Participants
Day 1: pre-dose and Day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours)
Sentinel Cohort, AUCinf: Area Under The Concentration-Time Curve From Time 0 To Infinity in Healthy Participants
Day 1: pre-dose and Day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours)

Secondary Endpoints

Main Cohort: Change From Baseline in Global Cognition Z-score
Baseline and Week 6 (for each study period)
Main Cohort: Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-071 in Parkinson Disease (PD) Participants
Day 42 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose
Main Cohort, Cmax: Maximum Observed Plasma Concentration for TAK-071 in PD Participants
Day 1 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Placebo + TAK-071 (PD Participants)EXPERIMENTALTAK-071 placebo-matching tablets, orally, once daily for up to first 6 weeks in Period 1, followed by ≥3 weeks washout period, followed by TAK-071 tablets, orally, once daily for up to next 6 weeks in Period 2.
TAK-071 + Placebo (PD Participants)EXPERIMENTALTAK-071 tablets, orally, once daily for up to first 6 weeks in Period 1, followed by ≥3 weeks washout period, followed by TAK-071 placebo-matching tablets, orally, once daily for up to next 6 weeks in Period 2.
Sentinel Cohort: Placebo (Healthy Participants)EXPERIMENTALA single dose of TAK-071 placebo-matching mg, tablet, orally, on Day 1.
Sentinel Cohort: TAK-071 7.5 mg (Healthy Participants)EXPERIMENTALA single dose of TAK-071 ≤ 7.5 milligrams (mg), tablet, orally, on Day 1.

Interventions

NameTypeDescription
TAK-071DRUGTAK-071 tablet.
PlaceboDRUGTAK-071 placebo-matching tablet.
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Eligibility Criteria

Age Range40 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites21

Key Inclusion Criteria: 1. Is an outpatient of any sex aged between 40 and ≤ 85 years, inclusive, at the time of consent. 2. Has a diagnosis of PD according to Movement Disorders Society (MDS) clinical diagnostic criteria for PD. Participants with DLB (i.e., dementia diagnosed before onset of motor...

Countries:United States
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Frequently asked questions about TAK-071

What is TAK-071?

TAK-071 is an investigational small molecule developed by Takeda Pharmaceutical Company Limited for Parkinson disease. It is a positive allosteric modulator of CHRM1, also known as the M1 muscarinic acetylcholine receptor. It has been studied in a Phase 2 clinical trial and is not approved for any indication.

What is TAK-071 used for in Parkinson disease?

TAK-071 is being developed as a potential treatment for Parkinson disease. It is designed to modulate the CHRM1 receptor, a muscarinic acetylcholine receptor subtype, and has been evaluated in a Phase 2 clinical trial that enrolled 64 participants with Parkinson disease and healthy participants.

What does TAK-071 target?

TAK-071 targets CHRM1, the M1 muscarinic acetylcholine receptor. It acts as a positive allosteric modulator, meaning it enhances the receptor's response to acetylcholine rather than directly activating it. This mechanism is being explored in Parkinson disease.

Who is developing TAK-071?

TAK-071 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical program evaluating TAK-071 in Parkinson disease.

What phase is TAK-071 in?

TAK-071 is in Phase 2 clinical development. A Phase 2 trial in Parkinson disease has been completed. TAK-071 is investigational and has not been approved by the FDA or any regulatory agency for any indication.

What clinical trials is TAK-071 in?

TAK-071 has been studied in a completed Phase 2 trial, NCT04334317, titled A Study of TAK-071 in People With Parkinson Disease. The trial enrolled 64 participants, was randomized, double-blind, and controlled, and was conducted in the United States.