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Trial record 89 of 2224 for:    Recruiting, Not yet recruiting, Available Studies | Renal

A Pharmacokinetic (PK) Study of Oral TAK-788 in Participants With Severe Renal Impairment (RI) and Normal Renal Function

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ClinicalTrials.gov Identifier: NCT04056455
Recruitment Status : Not yet recruiting
First Posted : August 14, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Brief Summary:
The purpose of this study is to characterize the single-dose plasma and urine PK of TAK-788 and its active metabolites (AP32960 and AP32914) in participants with severe RI compared to matched-healthy participants with normal renal function.

Condition or disease Intervention/treatment Phase
Renal Impairment Healthy Volunteers Drug: TAK-788 Phase 1

Detailed Description:

The drug being tested in this study is called TAK-788. This study is to assess the PK of TAK-788 and its active metabolites (including but not limited to AP32960 and AP32914) in participants with severe RI compared to matched-healthy participants with normal renal function.

The study will enroll approximately 16 participants. Participants will be assigned to 1 of the following 2 treatment groups:

  • Severe RI: TAK-788 80 mg
  • Normal Renal Function: TAK-788 80 mg

Healthy participants with normal renal function will be recruited to match severe RI by age (mean plus or minus [+-] 10 years), gender (+-2 participants per gender), and body mass index (BMI), (mean +- 10 percent [%]). All participants will be asked to take single dose of TAK-788 on Day 1.

This multi-center trial will be conducted in the United States. The overall time to participate in this study is 51 days. Participants will be contacted by telephone 30 days after the last dose of study drug for a follow-up assessment.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1 Pharmacokinetic Study of Oral TAK-788 in Participants With Severe Renal Impairment and Normal Renal Function
Estimated Study Start Date : February 10, 2020
Estimated Primary Completion Date : March 13, 2020
Estimated Study Completion Date : March 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Arm Intervention/treatment
Experimental: Severe RI: TAK-788 80 mg
TAK-788 80 milligram (mg), capsule, orally, a single dose on Day 1.
Drug: TAK-788
TAK-788 capsule.

Experimental: Normal Renal Function: TAK-788 80 mg
TAK-788 80 mg, capsule, orally, a single dose on Day 1.
Drug: TAK-788
TAK-788 capsule.




Primary Outcome Measures :
  1. Cmax: Maximum Observed Plasma Concentration for TAK-788 and its Active Metabolites (AP32960 and AP32914) [ Time Frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose ]
  2. Cmax,u: Maximum Observed Unbound Plasma Concentration for TAK-788 and its Active Metabolites (AP32960 and AP32914) [ Time Frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose ]
  3. AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788 and its Active Metabolites (AP32960 and AP32914) [ Time Frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose ]
  4. AUCinf,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788 and its Active Metabolites (AP32960 and AP32914) [ Time Frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose ]
  5. AUClast: Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for TAK-788 and its Active Metabolites (AP32960 and AP32914) [ Time Frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose ]
  6. AUClast,u: Area Under the Unbound Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for TAK-788 and its Active Metabolites (AP32960 and AP32914) [ Time Frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose ]
  7. Combined Molar Unbound Cmax, for TAK-788 and its Active Metabolites (AP32960 and AP32914) [ Time Frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose ]
  8. Combined Molar Unbound AUClast, for TAK-788 and its Active Metabolites (AP32960 and AP32914) [ Time Frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose ]
  9. Combined Molar Unbound AUCinf, for TAK-788 and its Active Metabolites (AP32960 and AP32914) [ Time Frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose ]
  10. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788 and its Active Metabolites (AP32960 and AP32914) [ Time Frame: : Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose ]
  11. t1/2z: Terminal Disposition Phase Half-life for TAK-788 and its Active Metabolites (AP32960 and AP32914) [ Time Frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose ]
  12. λz: Terminal Disposition Phase Rate Constant for TAK-788 and its Active Metabolites (AP32960 and AP32914) [ Time Frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose ]
  13. CL/F: Apparent Clearance After Extravascular Administration for TAK-788 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose ]
  14. CLu/F: Apparent Clearance for Unbound Drug After Extravascular Administration for TAK-788 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose ]
  15. Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-788 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose ]
  16. Vz,u/F: Apparent Volume of Distribution for Unbound Drug During the Terminal Disposition Phase After Extravascular Administration for TAK-788 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose ]
  17. Aet: Amount of Drug Excreted in Urine From Time 0 to time t for TAK-788 and its Active Metabolites (AP32960 and AP32914) [ Time Frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose ]
  18. fe,t: Fraction of Administered Dose Excreted in Urine From Time 0 to Time t TAK-788 and its Active Metabolites (AP32960 and AP32914) [ Time Frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose ]
  19. CLR: Renal Clearance for TAK-788 and its Active Metabolites (AP32960 and AP32914) [ Time Frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose ]

Secondary Outcome Measures :
  1. Plasma Protein Binding of TAK-788 and its Active Metabolites (AP32960 and AP32914) [ Time Frame: Day 1 at multiple time points (up to 24 hours) post-dose ]
  2. Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to 30 days after the last of study drug (Day 31) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion Criteria for Healthy Participants:

  1. Continuous non-smoker or moderate smoker (less than or equal to [<=]10 cigarettes/day or the equivalent) before screening. Participant must agree to consume no more than 5 cigarettes or equivalent/day from the 7 days prior to TAK-788 dosing and throughout the period of PK sample collection.
  2. Body mass index (BMI) greater than (>=) 18.0 and less than (<=) 39.0 kilogram per square meter (kg/m^2), at screening. Participants will be matched to RI participants by BMI (mean +- 10%) at screening. At least 50% of the participants will be required to be of BMI >=18.0 and <=35.0 kg/m^2, at screening.
  3. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the Investigator or designee. Has liver function tests including alanine aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline phosphatase (ALP), and total bilirubin within the upper limit of normal at screening and at check-in.
  4. Baseline estimated glomerular filtration rate (eGFR) >=90 milliliter per minute 1.73 square meter (mL/min/1.73 m^2) based on the Modification of Diet in Renal Disease (MDRD) equation at screening.
  5. Normal baseline spirometry for forced vital capacity (FVC) and Forced expiratory volume (FEV)1/FVC within 7 days prior to dosing based on the following normal FVC and FEV1/FVC range:

    • 18 to 39 years of age: >=80% of predicted normal.
    • 40 to 59 years of age: >=75% of predicted normal.
    • 60 to 80 years of age: >=70% of predicted normal.

Inclusion Criteria for Participants with RI:

  1. Continuous non-smoker or moderate smoker (≤10 cigarettes/day or the equivalent) before screening. Participant must agree to consume no more than 5 cigarettes or equivalent/day from the 7 days prior to dose of TAK-788 and throughout the period of PK sample collection.
  2. BMI >=18.0 and <=39.0 kg/m^2, at screening. At least 50% of the participants will be required to be of BMI >=18.0 and ≤35.0 kg/m^2, at screening.
  3. Aside from RI, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, ECGs, and screening clinical laboratory profiles, as deemed by the Investigator or designee.
  4. Baseline eGFR <30 mL/min/1.73 m^2 not on dialysis based on the MDRD equation at screening.
  5. Has a diagnosis of chronic (>6 months), stable (no significant changes in renal function [<30%] in the 30 days preceding screening; no acute episodes of illness within the previous 2 months due to deterioration in renal function) renal insufficiency. Participants with RI may have related medical conditions consistent with their disease (example, mild diabetes) that are stable for at least 3 months prior to screening, in the opinion of the Investigator or designee.
  6. Normal baseline spirometry for FVC and FEV1/FVC within 7 days prior to dosing based on the following normal FVC and FEV1/FVC range:

    • 18 to 39 years of age: >=80% of predicted normal.
    • 40 to 59 years of age: >=75% of predicted normal.
    • 60 to 80 years of age: >=70% of predicted normal.

Exclusion Criteria

  1. Seated heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at screening.
  2. Seated blood pressure is less than 90/40 millimeters of mercury (mmHg) or greater than 180/100 mmHg at screening.
  3. QT interval with Fridericia's correction (QTcF) interval is >=450 millisecond (msec) in males or >=470 msec in females or has ECG findings deemed abnormal with clinical significance by the Investigator or designee at screening
  4. RI participants: QTcF interval is >500 msec or has ECG findings deemed abnormal with clinical significance by the Investigator or designee at screening.
  5. Unable to refrain from or anticipates the use of any medication or substance (including prescription or over-the-counter, vitamin supplements, natural or herbal supplements) as indicated in (Prohibitions and Concomitant Medication) for the prohibited time period.
  6. Been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to dosing and throughout the study.
  7. Donation of blood or significant blood loss within 56 days prior to dosing.
  8. Plasma donation within 7 days prior to dosing.
  9. Positive results at screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056455


Contacts
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Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

Locations
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United States, Florida
Clinical Pharmacology of Miami Not yet recruiting
Hialeah, Florida, United States, 33014
Orlando Clinical Research Center Not yet recruiting
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
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Study Director: Medical Director Millennium Pharmaceuticals, Inc.

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Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04056455     History of Changes
Other Study ID Numbers: TAK-788-1007
U1111-1236-7343 ( Registry Identifier: WHO )
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda ( Millennium Pharmaceuticals, Inc. ):
Drug Therapy
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases