A Study of TAK-105 in Healthy Adults

NCT04964258 | Completed Phase 1 Results FDA Drug

• 1 other identifier: TAK-105-1001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

It is hoped that in the future, TAK-105 will be used to help treat people with nausea and vomiting. The main aims of this study are as follows:

• To check for side effects from TAK-105 in healthy adults.
• To learn how much TAK-105 they can receive without getting side effects from it. Participants will receive either TAK-105 as TAK-105-a or TAK-105-b (depending upon the part they are enrolled in) or a placebo as an injection under the skin (sub-cutaneous injection). A placebo looks like TAK-105-a or TAK-105-b but will not have any medicine in it. Three times as many participants will receive TAK-105-a or TAK-105-b than placebo. The study will have 6 parts. Each part will have several small groups of participants, called cohorts. Participants will only be in 1 cohort in 1 part of the study. Part 1: Participants will check into the study clinic to receive a single dose of TAK-105-a or placebo and will stay in the clinic for about 10 days. Then, participants return to the clinic for follow-up visits up to about 60 days after the dose. Part 2: Participants will check into the study clinic to receive TAK-105-a or placebo once a week for 4 weeks, and will stay in the clinic for about 26 days. Then, participants return to the clinic for follow-up visits up to about 60 days after last dose. Part 3: Participants will check into the study clinic to receive 2, 3 or 4 weekly doses of TAK-105-a or placebo. Their clinic stay will be for 10 to 24 days depending which cohort they are in. Then, participants return to the clinic for follow-up visits up to about 28 days after last dose. Part 4: Participants will check into the study clinic to receive 2 doses (once a week for 2 weeks) of TAK-105-a or placebo and will stay in the study clinic for about 12 days. They will return to the clinic later (in about 1-3 weeks) for another (third) dose and will stay for 2 days after the third dose. Then, participants return to the clinic for follow-up visits up to about 3 months after first dose. Part 5a: Participants will check into the study clinic to receive a single dose of TAK-105-a or placebo and will stay in the clinic for about 10 days. Then, participants return to the clinic for follow-up visits up to about 60 days after the dose. Part 5b: Participants will check into the study clinic to receive TAK-105-a or placebo once a week for 4 weeks, and will stay in the clinic for about 26 days. Then, participants return to the clinic for follow-up visits up to about 60 days after last dose. Part 5b will be optional, depending on the pharmacokinetic (PK) and safety data observed in Part 2. Part 6: Participants will check into the study clinic to receive a single dose of TAK-105-b or placebo and will stay in the clinic for about 10 days. Then, participants return to the clinic for follow-up visits up to about 60 days after the dose.

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With At Least One Treatment-emergent Adverse Event (TEAEs)

  An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE that started or worsened after the first dose of the study treatment and last dose of study treatment.

  Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82

Secondary Outcomes (1)

• Number of Participants Based on Antidrug Antibody (ADA) Status

  Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82

Other Outcomes (14)

• Parts 1, and 2, Cmax: Maximum Observed Plasma Concentration for TAK-105

  Part 1: Day 1 pre-dose and at multiple timepoints (up to Day 60) post-dose; Part 2: Day 1 pre-dose and at multiple timepoints (up to Day 6) post-dose; Part 2: Day 22 pre-dose and at multiple timepoints (up to Day 82) post-dose

• Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-105

  Part 1: Day 1 pre-dose and at multiple timepoints (up to Day 60) post-dose

• Parts 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-105

  Part 1: Day 1 pre-dose and at multiple timepoints (up to Day 60) post-dose

Study Arms (11)

Part 1: Placebo

PLACEBO COMPARATOR

TAK-105-a matching-placebo, injection, subcutaneously, once on Day 1.

Drug: TAK-105-a Placebo

Part 1: TAK-105 Dose 1

EXPERIMENTAL

TAK-105-a Dose 1, injection, subcutaneously, once on Day 1.

Drug: TAK-105-a

Part 1: TAK-105 Dose 2

EXPERIMENTAL

TAK-105-a Dose 2, injection, subcutaneously, once on Day 1.

Drug: TAK-105-a

Part 1: TAK-105 Dose 3

EXPERIMENTAL

TAK-105-a Dose 3, injection, subcutaneously, once on Day 1.

Drug: TAK-105-a

Part 1: TAK-105 Dose 4

EXPERIMENTAL

TAK-105-a Dose 4, injection, subcutaneously, once on Day 1.

Drug: TAK-105-a

Part 1: TAK-105 Dose 5

EXPERIMENTAL

TAK-105-a Dose 5, injection, subcutaneously, once on Day 1.

Drug: TAK-105-a

Part 1: TAK-105 Dose 6

EXPERIMENTAL

TAK-105-a Dose 6, injection, subcutaneously, once on Day 1.

Drug: TAK-105-a

Part 1: TAK-105 Dose 7

EXPERIMENTAL

TAK-105-a Dose 7, injection, subcutaneously, once on Day 1.

Drug: TAK-105-a

Part 2: Placebo

PLACEBO COMPARATOR

TAK-105-a matching-placebo, injection, subcutaneously, once weekly for 4 weeks.

Drug: TAK-105-a Placebo

Part 2: TAK-105 Dose 1A

EXPERIMENTAL

TAK-105-a Dose 1A, injection, subcutaneously, once weekly for up to 4 weeks.

Drug: TAK-105-a

Part 2: TAK-105 Dose 2A

EXPERIMENTAL

TAK-105-a Dose 2A, injection, subcutaneously, once weekly for 1 week.

Drug: TAK-105-a

Interventions

TAK-105-a DRUG

TAK-105-a subcutaneous solution.

Part 1: TAK-105 Dose 1; Part 1: TAK-105 Dose 2; Part 1: TAK-105 Dose 3; Part 1: TAK-105 Dose 4; Part 1: TAK-105 Dose 5; Part 1: TAK-105 Dose 6; Part 1: TAK-105 Dose 7; Part 2: TAK-105 Dose 1A; Part 2: TAK-105 Dose 2A

TAK-105-a Placebo DRUG

TAK-105-a placebo-matching solution.

Part 1: Placebo; Part 2: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For All Cohorts
• 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).
• Continuous nonsmoker who has not used nicotine and tobacco-containing products for at least 3 months prior to screening and through discharge.
• Be judged to be in good health (example, no evidence of psychiatric, hepatic, renal, pulmonary, or cardiovascular disease) by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, electrocardiogram (ECG), and vital sign measurements performed at the screening visit and before administration of the initial dose of study drug or invasive procedure.
• For Japanese participants in Part 5 (Cohorts 28 to 32 only):
• Has 2 Japanese parents and 4 Japanese grandparents, as confirmed by interview.

You may not qualify if:

• Participated in another investigational study within 4 weeks (or based on local regulations) or within 5 half-lives of the investigational product before the screening visit. The 4-week or 5 half-lives window will be derived from the date of the last dose and/or adverse event (AE) related to the study procedure in the previous study to the screening visit of the current study.
• Has a history of significant multiple and/or severe allergies (example, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food.
• Has a known hypersensitivity or contraindication to any component of TAK 105.
• Has positive pregnancy test or is lactating or breastfeeding.
• Has known or suspected current coronavirus disease 2019 (COVID-19) infection or is at risk of COVID-19 infection as assessed by the investigator.
• Unable to refrain from or anticipates using all medications including herbal medicines beginning approximately 7 days before administration of the first dose of study drug, throughout the study until the last follow-up visit.
• With history or presence of:
• or more incidences of syncope (example, vasovagal) within the last 5 years prior to screening;
• A family history of unexplained sudden death or channelopathy;
• Brugada syndrome (RBBB \[right bundle branch block\] pattern with ST-elevation in leads V1 V3);
• CV or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, stroke, sick sinus syndrome, pulmonary congestion, symptomatic or significant cardiac arrhythmia, supraventricular or ventricular tachycardia, second-degree atrioventricular (AV) block type 2, third degree AV block, prolonged QT interval with Fridericia correction method (QTcF) interval, hypokalemia, hypomagnesemia, or conduction abnormalities;
• Risk factors for Torsade de Pointes (example, heart failure, cardiomyopathy, or family history of Long QT Syndrome);
• Any clinically significant ECG findings or medical history including: long or short QTcF (over 450 milli second \[msec\] or less than 360 msec), bifascicular block or QRS greater than equal to (\>=)120 msec or PR interval \> 200 msec at screening or Day 1 pre-Hour 0;
• Has a documented history of sinus bradycardia less than (\<) 45 beats per minute \[bpm\]) based upon vital signs assessments, sinoatrial block as evidenced on ECG or sinus pause \>=3 seconds on ECG or predose telemetry.
• Has an average semi recumbent blood pressure (BP) less than 90 (systolic) and 60 (diastolic) millimeter of mercury (mmHg) or greater than 140/90 mmHg from screening to predose, inclusive.

Sponsors & Collaborators

• Takeda: lead

Study Sites (3)

Celerion

Tempe, Arizona, 85283, United States

Location

PPD Development, LP

Las Vegas, Nevada, 89113, United States

Location

PPD Development, LP

Austin, Texas, 78744, United States

Location

Related Links

• To obtain more information on the study, click on this link.

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 16, 2021
• Study Start: July 26, 2021
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: August 2, 2024
• Results First Posted: August 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (3)