A Study of the Interaction of Other Drugs With TAK-279 in Healthy Adults

NCT06290050 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: TAK-279-1006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of this study is to find out how several doses of TAK-279 affects the body of healthy adults and processes midazolam and repaglinide (pharmacokinetics or PK). Another aim is to learn about the side effects of TAK-279 and how well it is tolerated when given to healthy adults either alone or together with midazolam or repaglinide. During the study, participants will need to stay at the clinic for 19 days. Blood samples will be taken at several timepoints during the study. The study drug will be given by mouth (orally).

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (3)

• Cmax: Maximum Observed Plasma Concentration for Midazolam and Repaglinide When Administered Alone and With TAK-279

  Period 1-Midazolam Alone: Day 1 predose up to 24 hours (h) postdose; Repaglinide Alone: Day 2 predose up to 16 h postdose; Period 2-Midazolam, With TAK-279: Day 14 predose up to 24 h postdose; Repaglinide with TAK-279:Day 15 predose up to 16 h postdose

• AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Midazolam and Repaglinide When Administered Alone and With TAK-279

  Period 1-Midazolam Alone: Day 1 predose up to 24 hours (h) postdose; Repaglinide Alone: Day 2 predose up to 16 h postdose; Period 2-Midazolam, With TAK-279: Day 14 predose up to 24 h postdose; Repaglinide with TAK-279:Day 15 predose up to 16 h postdose

• AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Midazolam and Repaglinide When Administered Alone and With TAK-279

  Period 1-Midazolam Alone: Day 1 predose up to 24 hours (h) postdose; Repaglinide Alone: Day 2 predose up to 16 h postdose; Period 2-Midazolam, With TAK-279: Day 14 predose up to 24 h postdose; Repaglinide with TAK-279:Day 15 predose up to 16 h postdose

Secondary Outcomes (1)

• Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI)

  From Day 1 of Period 1 up to 14 days after the last dose of TAK-279 in Period 2 (up to 29 days)

Study Arms (4)

Treatment A: Midazolam 2 mg

EXPERIMENTAL

Midazolam 2 mg (1 milliliter \[mL\] of 2 milligram per milliliter \[mg/mL\]), syrup, orally, on Day 1 of Period 1.

Drug: Midazolam

Treatment B: Repaglinide 0.5 mg

EXPERIMENTAL

Repaglinide 0.5 mg (1\*0.5 mg), tablets, orally, on Day 2 of Period 1.

Drug: Repaglinide

Treatment C + Treatment A: TAK-279 Dose 1 + Midazolam 2 mg

EXPERIMENTAL

TAK-279 Dose 1, capsules, orally, on Days 1 through 15 of Period 2 followed by Midazolam 2 mg (1 mL of 2 mg/mL), syrup, orally, on Day 14 of Period 2.

Drug: Midazolam; Drug: TAK-279

Treatment C + Treatment B: TAK-279 Dose 1 + Repaglinide 0.5 mg

EXPERIMENTAL

TAK-279 Dose 1, capsules, orally, on Days 1 through 15 of Period 2 followed by Repaglinide 0.5 mg (1\*0.5 mg), tablets, orally, on Day 15 of Period 2.

Drug: Repaglinide; Drug: TAK-279

Interventions

Midazolam DRUG

Midazolam syrup.

Treatment A: Midazolam 2 mg; Treatment C + Treatment A: TAK-279 Dose 1 + Midazolam 2 mg

Repaglinide DRUG

Repaglinide tablets.

Treatment B: Repaglinide 0.5 mg; Treatment C + Treatment B: TAK-279 Dose 1 + Repaglinide 0.5 mg

TAK-279 DRUG

TAK-279 capsules.

Treatment C + Treatment A: TAK-279 Dose 1 + Midazolam 2 mg; Treatment C + Treatment B: TAK-279 Dose 1 + Repaglinide 0.5 mg

Eligibility Criteria

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

You may qualify if:

• Continuous non-smoker who has not used nicotine and tobacco containing products for at least 3 months prior to the first dosing based on subject self-reporting.
• Body mass index (BMI) greater than or equal to (\>=) 18.0 and less than or equal to (\<=) 32.0 kilogram per square meter (kg/m\^2) at the screening visit.
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and electrocardiograms (ECGs), as deemed by the investigator or designee, including the following:
• Seated blood pressure (BP) is \>=90/40 millimeter of mercury (mmHg) and \<=140/90 mmHg at the screening visit.
• Seated pulse rate (PR) is \>=40 beats per minute (bpm) and \<=99 bpm at the screening visit.
• ECG findings considered normal or not clinically significant by the investigator or designee at the screening visit.
• Estimated glomerular filtration rate (eGFR) \>=80 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) at the screening visit.
• Liver function tests including Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP), and total bilirubin \<= ULN at the screening visit and at check-in.

You may not qualify if:

• Participants must not be enrolled in the study if they meet any of the following criteria:
• Fasting glucose \>125 milligram per deciliter (mg/dL) at the screening visit.
• Has a history or presence of any of the following:
• Active infection or febrile illness within 7 days prior to first dosing, as assessed by the investigator or designee.
• Symptoms suggestive of systemic or invasive infection requiring hospitalization or treatment within 8 weeks prior to first dosing.
• Chronic or recurrent bacterial disease, including but not limited to chronic pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or chronic skin ulcerations/infections or fungal infections (except superficial nailbed mycosis).
• An infected joint prosthesis unless that prosthesis has been removed or replaced greater than 60 days prior to first dosing.
• Known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy.
• Solid organ transplant.
• Diabetes or prior episode(s) of hypoglycemia.
• Has history or presence of alcoholism and/or drug abuse within the past 2 years prior to first dosing, as determined by the investigator or designee.
• History or presence of hypersensitivity or idiosyncratic reaction to the study drugs.
• History or presence of ventricular dysfunction or risk factors for Torsades de Pointes (example, heart failure, cardiomyopathy, family history of Long QT Syndrome).
• Positive urine drug or alcohol results at the screening visit or check-in.
• Unable to refrain from or anticipates the use of:

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

Related Links

• To obtain more information about this study, click this link

MeSH Terms

Interventions

Midazolam; repaglinide

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 4, 2024
• Study Start: March 29, 2024
• Primary Completion: May 3, 2024
• Study Completion: May 16, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05

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)