Study to Evaluate Absorption, Metabolism, and Excretion, of TAK-994 in 6 Healthy Male Adults

NCT04833049 | Completed Phase 1 FDA Drug

• 1 other identifier: TAK-994-1004
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to understand how TAK-994 is processed by the body. This study will require participants to stay at the clinical research unit for 3 weeks to be monitored after receiving TAK-994.

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (4)

• Part A: Percent Absolute Bioavailability (%F) for TAK-994

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

• Part B: Percentage of Total Radioactivity (TRA) in Urine (Cum Percent [%] Dose [UR]) Relative to the Administered Radioactive Dose

  Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

• Part B: Percentage of TRA in Feces (Cum%Dose[FE]) Relative to the Administered Radioactive Dose

  Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

• Part B: Percentage of TRA Recovered in in the Urine and Feces Combined (Combined Cum%Dose) Relative to the Administered Radioactive Dose

  Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Secondary Outcomes (19)

• Part A, Ceoi: Plasma Concentration at the end of Infusion for [14C]TAK-994

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

• Part A, CL: Total Clearance for [14C]TAK-994

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

• Part A, Vss: Volume of Distribution at Steady State After Intravenous Administration for [14C]TAK-994

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

• Part A, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-994 and [14C]TAK-994

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

• Part A, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-994 and [14C]TAK-994

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

Study Arms (1)

TAK-994 Dose 1 + [14C]TAK-994 Dose 2 + [14C]TAK-994 Dose 3

EXPERIMENTAL

TAK-994 Dose 1, tablet, orally, on Day 1, followed by \[14C\]TAK-994 Dose 2, infusion, intravenously, on Day 1 of Part A, followed by a washout period of at least 8 days, further followed by \[14C\]TAK-994 Dose 3, suspension, orally, on Day 1 of Part B.

Drug: TAK-994 Oral Tablet; Drug: [14C]TAK-994 Intravenous Infusion; Drug: [14C]TAK-994 Oral Suspension

Interventions

TAK-994 Oral Tablet DRUG

TAK-994 tablet.

TAK-994 Dose 1 + [14C]TAK-994 Dose 2 + [14C]TAK-994 Dose 3

[14C]TAK-994 Intravenous Infusion DRUG

\[14C\]TAK-994 intravenous infusion.

TAK-994 Dose 1 + [14C]TAK-994 Dose 2 + [14C]TAK-994 Dose 3

[14C]TAK-994 Oral Suspension DRUG

\[14C\]TAK-994 oral suspension.

TAK-994 Dose 1 + [14C]TAK-994 Dose 2 + [14C]TAK-994 Dose 3

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) greater than or equal to (\>=) 18.0 and less than (\<) 32.0 kilogram per square meter (kg/m\^2) at the screening.
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the Investigator or designee.
• Continuous non-smoker who has not used nicotine-containing products for at least 90 days prior to the first dosing and throughout the study, based on participant self-reporting.
• Agrees to comply with any applicable contraceptive requirements of the protocol.
• Agree not to donate sperm from the first dosing until 95 days after the last dosing.
• Agree and able to remain in the clinical research unit (CRU) for the duration of the study.
• Understands the study procedures in the ICF, and be willing and able to comply with the protocol.
• Able to swallow oral suspensions.

You may not qualify if:

• Mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
• History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator or designee.
• History or presence of gastritis, gastrointestinal tract, hepatic disorder, cholecystectomy, history of treated or untreated Helicobacter pylori, ulcer disease, or other clinical condition which, in the opinion of the Investigator or designee, may affect the absorption, distribution, metabolism, or elimination of study drug.
• History of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
• History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing per the Diagnostic and Statistical Manual of Mental Disorders-V criteria.
• History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
• Current or past history of epilepsy, seizure, convulsion, tremor, or related symptoms.
• Positive urine drug or alcohol results at screening or check-in.
• Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
• Seated blood pressure is less than 90/40 millimeter of mercury (mmHg) or greater than 140/90 mmHg at screening.
• Seated heart rate is lower than 45 beats per minute (bpm) or higher than 100 bpm at screening.
• Orthostatic vital sign results with a decrease in systolic greater than (\>) 20 mmHg or decrease in diastolic \>10 mmHg, and increase in pulse of \>20 bpm.
• QT interval corrected for heart rate using Frederica's equation (QTcF) is \>450 milliseconds (msec) or ECG findings are deemed abnormal with clinical significance by the Investigator or designee at screening.
• Liver function tests including alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>1.5\*upper limit of normal (ULN) at screening or check-in.
• Estimated creatinine clearance \<90 milliliter per minute (mL/min) at screening.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Related Links

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

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 6, 2021
• Study Start: April 14, 2021
• Primary Completion: June 20, 2021
• Study Completion: June 20, 2021
• Last Updated: June 29, 2021

Record last verified: 2021-06

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 (1)