A Study of TAK-510 in Healthy Adults

NCT04731922 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: TAK-510-1001U1111-1261-6974
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 2

Brief Summary

This is a study of TAK-510 for people with symptoms of feeling sick (nausea) or being sick (vomiting). The main aims of the study are to check if healthy adults have side effects from TAK-510 and to check how much TAK-510 they can receive without getting side effects from it. The study will be in 3 parts. Participants will take part in only 1 of the 3 parts of the study. At the first visit, the study doctor will check if each person can take part. For those who can take part, they will be placed in 1 of many small groups. The 1st groups will join Part 1 of the study, the 2nd groups will join Part 2 and the 3rd groups will join Part 3. They will receive an injection under the skin of either TAK-510 or placebo. In this study, a placebo will look like the TAK-510 injection but will not have any medicine in it. In Part 1, the 1st group of participants will receive 1 injection of either TAK-510 or placebo. Different participants within this group will receive lower to higher doses of TAK-510. The participants in this group will stay in the clinic for 4 days after their injection for some tests and check for any side effects from their treatment. In Part 2, the 2nd group of participants will receive an injection of either TAK-510 or placebo, once a day for 5 days. Different participants within this group will receive lower to higher doses of TAK-510. The participants in this group will stay in the clinic for 9 days after their 1st injection for some tests and check for any side effects from their treatment. In Part 3, the 3rd group of participants will visit the clinic 2 times. At the 1st visit, they will receive an injection either of TAK-510 or placebo, once a day for 7 days. Each participant in this group will receive lower to higher doses of TAK-510. They will stay in the clinic for 8 days after their 1st injection for some tests and check for any side effects from their treatment. At the 2nd clinic visit, each participant will receive 1 single injection of TAK-510 or placebo. This will happen 7 days after their last injection from the previous clinic visit. They will receive the same dose as their previous dose. They will stay in the clinic for 3 days for some tests and check for any side effects from their treatment. After treatment, all participants in the study will return to the clinic for a weekly check-up visit for up to 3 weeks.

Conditions

Healthy Participants

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (4)

• Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose

  Vital signs included systolic and diastolic blood pressure, body temperature, pulse rate (PR), respiratory rate, orthostatic blood pressure and pulse rate assessments. The markedly abnormal value (MAV) criteria for vital signs were systolic blood pressure (SBP) less than (\<) 85 millimeter of mercury (mmHg), greater than (\>) 180 mmHg; diastolic blood pressure (DBP) \<50 mmHg, \>110 mmHg; body temperature \<35.6 degree Celsius, \>37.7 degree Celsius; PR \<50 beats per minute (bpm), \>120 bpm; respiratory rate \<12 breaths per minute (breaths/minute), \>16 breaths/minute; orthostatic hypotension decrease in SBP greater than or equal to (\>=) 20 mmHg or a decrease in DBP \>=10 mmHg on standing; orthostatic tachycardia defined as an increase of \>30 bpm or heart rate (HR) \>120 bpm on standing. Number of participants who met the MAV criteria for vital signs at least once post dose were reported.

  Parts 1 and 2: From the first dose of study drug up to Day 29

• Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose

  ECG included HR, PR, QT interval with Fridericia correction (QTcF) interval and QRS duration. The MAV criteria for 12-lead ECG parameters included heart rate \<50 bpm, \>120 bpm; PR interval less than or equal to (\<=)80 milliseconds (msec), \>=200 msec; QTcF interval \>=500 msec; QRS duration \<=80 msec, \>=120 msec. Number of participants who met the MAV criteria for ECG parameters at least once post dose were reported.

  Parts 1 and 2: From the first dose of study drug up to Day 29

• Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose

  Clinical laboratory parameters included tests for chemistry and hematology. The MAV criteria for laboratory value included hemoglobin \<0.8\*LLN,\>1.2\*ULN; hematocrit \<0.8\*LLN,\>1.2\*ULN;RBC count \<0.8\*LLN, \>1.2\*ULN;WBC count \<0.5\*LLN, \>1.5\*ULN; platelet count \<75\*10\^9 per liter, \>600\*10\^9 per liter; ALT \>3\*ULN; AST \>3\*ULN,GGT \>3\*ULN, normal baseline; \>2\*baseline,abnormal baseline; ALP\>3\*ULN, normal baseline; \>2\*baseline, abnormal baseline; total bilirubin \>1.5\*ULN, normal baseline; \>1.5\* baseline, abnormal baseline; albumin \<25g/L; total protein \<0.8\* LLN, \>1.2\*ULN; creatinine \>177 micromole per liter; blood urea nitrogen \>10.7 mmol/L; sodium \<130 mmol/L, \>150mmol/L; potassium \<3.0mmol/L, \>5.5 mmol/L; glucose \<3mmol/L, \>10mmol/L; chloride \<75mmol/L, \>126mmol/L; calcium corrected serum calcium of \<LLN-8.0 mg/dL; \<LLN-2.0mmol/L; ionized calcium \<LLN-1.0mmol/L; bicarbonate \<8.0mmol/L. Number of participants who met the MAV criteria for laboratory value at least once post dose were reported.

  Parts 1 and 2: From the first dose of study drug up to Day 29

• Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE)

  A TEAE was defined as an adverse event (AE) that started or worsened after first dose of the study treatment and within 30 days of last dose of study treatment. An AE was defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it did not necessarily had to have a causal relationship with the treatment. An AE could 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 was considered related to the drug.

  From the first dose of study drug until 30 days after last dose in Parts 1 and 2 (SRD Cohorts: up to Day 31, MRD Cohorts: up to Day 35)

Secondary Outcomes (8)

• Part 3, Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens

  Part 3: From the first dose of study drug up to Day 29

• Part 3, Number of Participants Who Met the Markedly Abnormal Criteria for ECG Parameters at Least Once Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens

  Part 3: From the first dose of study drug up to Day 29

• Part 3, Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens

  Part 3: From the first dose of study drug up to Day 29

• Part 3, Number of Participants Reporting One or More TEAE Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens

  Part 3: From the first dose of study drug until 30 days after last dose (up to Day 37)

• Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum

  Parts 1 and 2: From the first dose of study drug up to Day 29

Other Outcomes (22)

• Parts 1 and 2, Cmax: Maximum Observed Plasma Concentration for TAK-510

  Part 1, Day 1: pre-dose and at multiple time points (up to 96 hours) post-dose; Part 2, Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose

• Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-510

  Part 1, Day 1: pre-dose and at multiple time points (up to 96 hours) post-dose

• Part 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-510

  Part 1, Day 1: pre-dose and at multiple time points (up to 96 hours) post-dose

Study Arms (3)

TAK-510: Part 1

EXPERIMENTAL

TAK-510 at starting dose of 5 microgram (mcg) or placebo-matching solution, subcutaneously, once on Day 1. Staggered dosing will be done in the first cohort of Part A (Cohort 1). Staggered dosing in subsequent Cohorts (Cohorts 2-12 and 21-25) will be used based on emerging safety, tolerability, and PK data from Cohort 1 as determined in the dose escalation meeting.

Drug: TAK-510; Drug: TAK-510 Placebo

TAK-510: Part 2

EXPERIMENTAL

TAK-510 to be decided (TBD) or placebo-matching solution, subcutaneously, once daily from Day 1 through Day 5. Dose of MRD Cohorts (Cohorts 13-17 and 26-28) of Part 2 will be determined based on emerging safety, tolerability, and available PK data from Part 1 (SRD) and any available PK data from Part 2 as determined in the dose escalation meeting.

Drug: TAK-510; Drug: TAK-510 Placebo

TAK-510: Part 3

EXPERIMENTAL

TAK-510 TBD or placebo-matching solution, subcutaneously, once daily from Days 1 to 7. Dose of dose titration and redosing Cohorts (Cohorts 18-20) of Part 3 will be based on emerging safety, tolerability, and available PK data from Part 1 (SRD) and Part 2 (MRD) as determined in the dose escalation meeting. Single redosing will be performed on Day 14 after 7 days of washout period following the 7 days treatment period.

Drug: TAK-510; Drug: TAK-510 Placebo

Interventions

TAK-510 DRUG

TAK-510 solution.

TAK-510: Part 1; TAK-510: Part 2; TAK-510: Part 3

TAK-510 Placebo DRUG

TAK-510 placebo-matching solution.

TAK-510: Part 1; TAK-510: Part 2; TAK-510: Part 3

Eligibility Criteria

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

You may qualify if:

• Continuous nonsmoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to dosing and throughout the study.
• 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.

You may not qualify if:

• Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency antibody/antigen, at the screening visit.
• Had major surgery or donated or lost 1 unit of blood (approximately 500 milliliter \[mL\]) within 4 weeks before the screening visit.
• 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 2 days after discharge.
• Unable to refrain from or anticipates using marijuana or cannabis-containing products beginning approximately 7 days before administration of the first dose of study drug, throughout the study until after the last PK dose.
• Has had a previous major psychotic disorder.
• Has an average semirecumbent blood pressure (BP) less than 90/60 millimeter of mercury (mmHg) or greater than 140/90 mmHg from screening to predose, inclusive. Any assessments on Day -1, where 2 consecutive time point values do not meet this criterion must be discussed with the medical monitor for approval.
• Has a known or suspected current coronavirus disease 2019 (COVID-19) infection or is at risk of COVID-19 infection as assessed by the investigator.

Sponsors & Collaborators

• Takeda: lead

Study Sites (2)

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: January 27, 2021
• First Posted: February 1, 2021
• Study Start: February 3, 2021
• Primary Completion: July 24, 2022
• Study Completion: July 24, 2022
• Last Updated: March 4, 2024
• Results First Posted: March 4, 2024

Record last verified: 2023-07

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 (2)