A Study of the Interaction of TAK-279 With Substances That Have an Impact on Metabolism in Healthy Adults

NCT05995249 | Completed Phase 1 FDA Drug

• 1 other identifier: TAK-279-1002
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of this study is to find out how the body of a healthy adult processes TAK-279 (pharmacokinetics) when substances that either hinder or help the human metabolism such as erythromycin, phenytoin and efavirenz are given along with TAK-279. Other aim is to learn about side effects and how well it is tolerated when TAK-279 is given alone and together with substances that impact human metabolism. The participants will need to stay at the clinic for up to 26 days.

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (3)

• Parts 1, 2, and 3: Cmax: Maximum Observed Plasma Concentration for TAK-279

  Predose and at multiple timepoints post dose from Day 1 period 1 (length= 6 days) to period 2 Day 11 in Part 1 (length= 11 days), up to period 2 Day 19 in Part 2 (length= 19 days) and up to period 2 Day 16 in Part 3 (length= 16 days)

• Parts 1, 2, and 3: AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-279

  Predose and at multiple timepoints post dose from Day 1 period 1 (length= 6 days) to period 2 Day 11 in Part 1 (length= 11 days), up to period 2 Day 19 in Part 2 (length= 19 days) and up to period 2 Day 16 in Part 3 (length= 16 days)

• Parts 1, 2, and 3: AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for TAK-279

  Predose and at multiple timepoints post dose from Day 1 period 1 (length= 6 days) to period 2 Day 11 in Part 1 (length= 11 days), up to period 2 Day 19 in Part 2 (length= 19 days) and up to period 2 Day 16 in Part 3 (length= 16 days)

Secondary Outcomes (4)

• Parts 1, 2, and 3: Number of Participants with Treatment-emergent Adverse Events (TEAEs)

  From Day 1 of period 1 through period 2 Day 11 (up to approximately 65 days) in Part 1, up to period 2 Day 19 (up to approximately 73 days) in Part 2 and up to period 2 Day 16 (up to approximately 70 days) in Part 3

• Parts 1, 2, and 3: Number of Participants with Abnormal Vital Signs

  From Day 1 of period 1 through period 2 Day 11 (up to approximately 65 days) in Part 1, up to period 2 Day 19 (up to approximately 73 days) in Part 2 and up to period 2 Day 16 (up to approximately 70 days) in Part 3

• Parts 1, 2, and 3: Number of Participants with Abnormal Electrocardiogram Findings

  From Day 1 of period 1 through period 2 Day 11 (up to approximately 65 days) in Part 1, up to period 2 Day 19 (up to approximately 73 days) in Part 2 and up to period 2 Day 16 (up to approximately 70 days) in Part 3

• Parts 1, 2, and 3: Number of Participants with Abnormal Laboratory Values

  From Day 1 of period 1 through period 2 Day 11 (up to approximately 65 days) in Part 1, up to period 2 Day 19 (up to approximately 73 days) in Part 2 and up to period 2 Day 16 (up to approximately 70 days) in Part 3

Study Arms (3)

Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg

EXPERIMENTAL

Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg, on Day 5 and erythromycin 500 mg orally thrice daily (TID) on Day 1 through Day 10 of Period 2 in Part 1 of the study.

Drug: TAK-279; Drug: Erythromycin

Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg

EXPERIMENTAL

Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg on Day 14 and phenytoin 100 mg orally TID on Day 1 through Day 18 of Period 2 in Part 2 of the study.

Drug: TAK-279; Drug: Phenytoin

Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg

EXPERIMENTAL

Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg on Day 11 and efavirenz 600 mg orally once daily (QD) on Day 1 through Day 15 of Period 2 in Part 3 of the study.

Drug: TAK-279; Drug: Efavirenz

Interventions

TAK-279 DRUG

TAK-279 capsules

Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg; Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg; Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg

Erythromycin DRUG

Erythromycin tablets

Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg

Phenytoin DRUG

Phenytoin capsules

Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg

Efavirenz DRUG

Efavirenz tablets

Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg

Eligibility Criteria

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

You may qualify if:

• Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
• Healthy, adult, male or female of non-childbearing potential, 18-55 years of age, inclusive, at the screening visit.
• Male participants must follow protocol specified contraception guidance.
• Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting.
• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 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 is ≥ 40 beats per minute (bpm) and ≤ 99 bpm at the screening visit.
• Part 1 only: QTcF interval is ≤ 450 msec (males and females) and has ECG findings considered normal or not clinically significant by the Investigator or designee at the screening visit.
• Part 2 and 3: ECG findings considered normal or not clinically significant by the Investigator or designee at the screening visit.
• Estimated glomerular filtration rate (eGFR) ≥ 80 mL/min/1.73m\^2 at the screening visit.
• Liver function tests including Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP), and total bilirubin ≤ upper limit of normal (ULN) at the screening visit and at check-in.
• No clinically significant hypokalemia or hypomagnesemia at the screening visit.

You may not qualify if:

• Is 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 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.
• Has a history 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.
• Opportunistic infections (eg, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).
• Known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy.
• Liver or other solid organ transplant.
• 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, including macrolide antibiotics (Part 1 only; eg, erythromycin) or anti-seizure agents (Part 2 only; eg, phenytoin) or anti-viral drugs (Part 3 only; eg, efavirenz).
• Part 2 and Part 3 only: Any positive responses on the Columbia-Suicide Severity Rating Scale (C-SSRS) or has a risk of suicide according to the Investigator's or designee judgment based on the assessment of the C-SSRS at the screening visit or check-in or has made a suicide attempt within 12 months before the first dosing.
• Part 2 only: History of seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions which the Investigator or designee considers to be clinically significant.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Celerion - Tempe, AZ Site

Tempe, Arizona, 85283, United States

Location

Related Links

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

MeSH Terms

Interventions

Erythromycin; Phenytoin; efavirenz

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: August 11, 2023
• Primary Completion: December 18, 2023
• Study Completion: December 31, 2023
• Last Updated: February 6, 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 (1)