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Phase 1 Completed N=80 Randomized Double-blind Other

A Study of TAK-105 in Healthy Adults

Healthy Volunteers
Source: ClinicalTrials.gov NCT04964258 ↗
Enrolled (actual)
80
Serious AEs
7.5%
Results posted
Aug 2024
Primary outcomePrimary: Number of Participants With At Least One Treatment-emergent Adverse Event (TEAEs) — 6; 3; 4; 3 Participants

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With At Least One Treatment-emergent Adverse Event (TEAEs)
6; 3; 4; 3; 4; 3
SECONDARY
Number of Participants Based on Antidrug Antibody (ADA) Status
14; 6; 6; 6; 6; 6

Eligibility Criteria

Inclusion Criteria

For All Cohorts

  • Must have a body mass index (BMI) greater than or equal to (>=) 18.0 and less than or 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 ( =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.
  • From screening to Day -2, participants with an average semirecumbent heart rate (HR) 100 beats per minute (bpm) should be excluded. From Day -2 to predose, enrollment of participants with an average HR 100 bpm will be left to the judgment of the investigator, unless HR is =20 mmHg or a decrease in diastolic BP (DPB) >=10 mmHg at approximately 2 minutes of standing when compared with BP from the semirecumbent position at screening to predose assessments, inclusive.
  • Has postural orthostatic tachycardia, defined as an increase of >30 bpm or HR >120 bpm at approximately 2 minutes of standing, at screening to predose assessments, inclusive.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04964258). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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