A Study of TAK-279 in Healthy Adults on the Effect on ECG Measurements

NCT06258265 | Completed Phase 1 FDA Drug

• 1 other identifier: TAK-279-1001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of this study is to find out how more than one dose of TAK-279 changes the heart-rate corrected QT (QTc) interval of healthy adults. A QTc interval is a measurement on an electrocardiogram (ECG) and shows the time when the heart contracts until it finishes relaxing. Other aims are to learn about the effect of several doses of TAK-279 on other ECG measurements of healthy adults, how the body of a healthy adult processes TAK-279 and moxifloxacin (pharmacokinetics), and to learn about the side effects of TAK-279 and how well it is tolerated when given to healthy adults. The participants will be given TAK-279 and moxifloxacin or a placebo for 7 days. During the study, participants will need to stay at the clinic for 10 days.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Placebo-corrected Change From Baseline in QTc Interval (ΔΔQTc) for TAK-279

  Placebo-corrected QTc interval will be measured by continuous ECG recordings.

  Baseline, Days 1, 7, and 8

Secondary Outcomes (18)

• Change From Baseline in Heart Rate (HR [ΔHR]) for TAK-279

  Baseline, Days 1, 7, and 8

• Change From Baseline in QTc (ΔQTc) Interval for TAK-279

  Baseline, Days 1, 7, and 8

• Change From Baseline in PR Interval (ΔPR) for TAK-279

  Baseline, Days 1, 7, and 8

• Change From Baseline in QRS Interval (ΔQRS) for TAK-279

  Baseline, Days 1, 7, and 8

• Placebo-corrected Change From Baseline in HR (ΔΔHR) for TAK-279

  Baseline, Days 1, 7, and 8

Study Arms (4)

Cohort 1, Therapeutic Dose Cohort: TAK-279 + TAK-279 Placebo + Moxifloxacin Placebo

EXPERIMENTAL

Participants will receive TAK-279 Dose 1 and matching placebo, capsules, once daily (QD) on Days 1 to 7 with moxifloxacin matching placebo, capsule, once on Days 1 and 8.

Drug: TAK-279; Drug: TAK-279 Placebo; Drug: Moxifloxacin Placebo

Cohort 2, Supratherapeutic Dose Cohort: TAK-279 + Moxifloxacin Placebo

EXPERIMENTAL

Participants will receive TAK-279 Dose 2, capsules, QD on Days 1 to 7 with moxifloxacin matching placebo, capsule once on Days 1 and 8.

Drug: TAK-279; Drug: Moxifloxacin Placebo

Cohort 3A, Control Cohort: Moxifloxacin + TAK-279 Placebo + Moxifloxacin Placebo

EXPERIMENTAL

Participants will receive moxifloxacin Dose 3, over-encapsulated tablet on Day 1 with TAK-279 matching placebo, QD on Days 1 to 7 and moxifloxacin placebo, capsule, once on Day 8.

Drug: TAK-279 Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin Placebo

Cohort 3B, Control Cohort: TAK-279 Placebo + Moxifloxacin Placebo + Moxifloxacin

EXPERIMENTAL

Participants will receive moxifloxacin matching placebo, capsule on Day 1 with TAK-279 matching placebo, QD on Days 1 to 7 and moxifloxacin Dose 3, over-encapsulated tablet, once on Day 8.

Drug: TAK-279 Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin Placebo

Interventions

TAK-279 DRUG

TAK-279 capsule.

Cohort 1, Therapeutic Dose Cohort: TAK-279 + TAK-279 Placebo + Moxifloxacin Placebo; Cohort 2, Supratherapeutic Dose Cohort: TAK-279 + Moxifloxacin Placebo

TAK-279 Placebo DRUG

TAK-279 matching placebo capsule.

Cohort 1, Therapeutic Dose Cohort: TAK-279 + TAK-279 Placebo + Moxifloxacin Placebo; Cohort 3A, Control Cohort: Moxifloxacin + TAK-279 Placebo + Moxifloxacin Placebo; Cohort 3B, Control Cohort: TAK-279 Placebo + Moxifloxacin Placebo + Moxifloxacin

Moxifloxacin DRUG

Moxifloxacin over-encapsulated tablet.

Cohort 3A, Control Cohort: Moxifloxacin + TAK-279 Placebo + Moxifloxacin Placebo; Cohort 3B, Control Cohort: TAK-279 Placebo + Moxifloxacin Placebo + Moxifloxacin

Moxifloxacin Placebo DRUG

Moxifloxacin matching placebo capsule.

Cohort 1, Therapeutic Dose Cohort: TAK-279 + TAK-279 Placebo + Moxifloxacin Placebo; Cohort 2, Supratherapeutic Dose Cohort: TAK-279 + Moxifloxacin Placebo; Cohort 3A, Control Cohort: Moxifloxacin + TAK-279 Placebo + Moxifloxacin Placebo; Cohort 3B, Control Cohort: TAK-279 Placebo + Moxifloxacin Placebo + Moxifloxacin

Eligibility Criteria

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

You may qualify if:

• Understand the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.
• Healthy, adult, male or female, 18-55 years of age, inclusive, at the screening visit.
• Female participants of childbearing potential and non-sterilized male participants must follow protocol specified contraception guidance as described in protocol.
• Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first baseline cardiodynamic measurement (Day -1) based on participant self-reporting.
• BMI greater than or equal to (\>=) 18.0 and less than or equal to (\<=) 32.0 kilograms per meter square (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:
• Supine blood pressure is \>=90/40 millimeter of mercury (mmHg) and \<=140/90 mmHg at the screening visit.
• Supine pulse rate is \>=40 beats per minute (bpm) and \<=99 bpm at the screening visit.
• QTc using Fridericia's formula (QTcF) interval is \<=450 milliseconds (msec) (males) and \<=460 msec (female) at the screening visit.
• QRS interval \<=110 msec at the screening visit (if \>110 msec, result will be confirmed by a manual over read).
• PR interval \<=220 msec at the screening visit.
• eGFR \>=80 milliliter per minute per 1.73 meter square (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.
• Creatine phosphokinase (CPK) \<=ULN at the screening visit and at check-in.
• Amylase and lipase \<=ULN at the screening visit and at check-in.

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 baseline cardiodynamic measurement (Day -1), as assessed by the Investigator or designee.
• Symptoms suggestive of systemic or invasive infection requiring hospitalization or treatment within 8 weeks prior to first baseline cardiodynamic measurement (Day -1).
• 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 baseline cardiodynamic measurement (Day -1).
• Opportunistic infections (eg, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).
• Cancer or lymphoproliferative disease, with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
• Known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy.
• Liver, kidney, heart, or other solid organ transplant.
• Myasthenia gravis.
• Peripheral neuropathy.
• Has history or presence of alcoholism and/or drug abuse within the past 2 years prior to first baseline cardiodynamic measurement (Day -1), as determined by the Investigator or designee.

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

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; 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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: April 29, 2024
• Primary Completion: June 25, 2024
• Study Completion: July 9, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

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 (1)