TAK-020 Relative Bioavailability and Food Effect Study in Healthy Participants

NCT02723201 | Completed Phase 1 Results

• 4 other identifiers: TAK-020-1002U1111-1171-46502015-002635-1816/WA/0012
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the relative bioavailability of solid oral formulations of TAK-020 in comparison with single dose of TAK-020 oral solution formulation and to evaluate the food effect and potentially the dose proportionality of the optimal oral solid formulation.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Cmax: Maximum Observed Plasma Concentration for TAK-020

  Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose

• Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020

  Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose

• AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-020

  Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose

• Terminal Disposition Phase Half-life (T1/2z) in Plasma for TAK-020

  Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose

Secondary Outcomes (4)

• Number of Participants Who Experience at Least One or More Treatment-emergent Adverse Event (TEAE)

  Baseline up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)

• Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post Dose

  Baseline up to Day 2

• Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose

  Baseline up to Day 2

• Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose

  Baseline up to Day 2

Study Arms (7)

Part-1, Period 1: TAK-020 17.5 mg Oral Solution

EXPERIMENTAL

Single dose 17.5 milligram (mg), on Day 1, followed by 7 days of washout. Dose will be determined from TAK-020 single rising dose (SRD) trial.

Drug: TAK-020 Captisol Oral Solution

Part-1, Period 2: TAK-020 17.5 mg Co-crystal Tablet (CCT)

EXPERIMENTAL

Single oral dose 17.5 mg, on Day 1, followed by 7 days of washout. Dose will be the same as Part 1, Period 1.

Drug: TAK-020 CCT

Part-1, Period 3:TAK-020 17.5 mg Solid Dispersion Tablet (SDT)

EXPERIMENTAL

Single oral dose 17.5 mg, on Day 1, followed by 7 days of washout. Dose will be the same as Part 1, Period 1.

Drug: TAK-020 SDT

Part-1, Period 4:TAK-020 17.5 mg Immediate Release Tablet(IRT)

EXPERIMENTAL

Single oral dose 17.5 mg, on Day 1, followed by 7 days of washout. Dose will be the same as Part 1, Period 1.

Drug: TAK-020 IRT

Part 2, Period 1: TAK-020 25 mg CCT

EXPERIMENTAL

Participants will be randomized to AB or BA crossover where A= Fasted, B =Fed. Sequence I: Single oral dose TAK-020 25 mg, Fasted (A), 7 days washout, single oral dose TAK-020 Fed (B) Sequence II: Single oral dose TAK-020 25 mg, Fed (B), 7 days washout, single oral dose TAK-020 Fasted (A) Dose will be determined from SRD trial and Part 1.

Drug: TAK-020 CCT

Part- 3 Cohort 1: TAK-020 Solid Formulation

EXPERIMENTAL

Single oral dose on Day 1. Dose will be determined from SRD trial and Parts 1 and 2

Drug: TAK-020 Solid Formulation

Part 3 Cohort 2: TAK-020 Solid Formulation

EXPERIMENTAL

Single oral dose on Day 1. Dose will be determined from SRD trial and Parts 1 and 2

Drug: TAK-020 Solid Formulation

Interventions

TAK-020 Captisol Oral Solution DRUG

TAK-020 solution.

Part-1, Period 1: TAK-020 17.5 mg Oral Solution

TAK-020 CCT DRUG

TAK-020 co-crystal tablet

Part-1, Period 2: TAK-020 17.5 mg Co-crystal Tablet (CCT)

TAK-020 SDT DRUG

TAK-020 Solid dispersion tablet.

Part-1, Period 3:TAK-020 17.5 mg Solid Dispersion Tablet (SDT)

TAK-020 IRT DRUG

TAK-020 immediate release tablet.

Part-1, Period 4:TAK-020 17.5 mg Immediate Release Tablet(IRT)

TAK-020 Solid Formulation DRUG

TAK-020 solid formulation

Part 3 Cohort 2: TAK-020 Solid Formulation; Part- 3 Cohort 1: TAK-020 Solid Formulation

Eligibility Criteria

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

You may qualify if:

• Is capable of understanding and complying with protocol requirements.
• Is legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations.
• Is a healthy adult male or female.
• Is aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.
• Weighs at least 45 kilogram (kg) and has a body mass index (BMI) between 18 and 32 kilogram per square meter (kg/m\^2), inclusive at Screening and Day -1.
• Male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 90 days after last dose of study medication.

You may not qualify if:

• Has received any investigational compound within 30 days prior to Screening.
• Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
• Has a known hypersensitivity to any component of the formulation of TAK-020, Captisol, or related compounds.
• Has a positive urine drug result for drugs of abuse or a positive breath alcohol screen at Screening or Check-in (Day -1).
• Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as 4 or more alcoholic units per day) within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
• Has taken any excluded medication, supplements, or food products listed in Prohibited Medications and Foods table.
• If female, is pregnant or lactating or intending to become pregnant before, during or within 3 months after exit from this study (90 days post last dose); or intending to donate ova during such time period.
• If male, the participant intends to donate sperm during the course of this study or for 90 days after the last dose of study drug.
• Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash.
• Has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (that is, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent \[more than once per week\] occurrence of heartburn, or any surgical intervention \[example, cholecystectomy\]).
• Has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.
• Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in Day -1. Cotinine test is positive at Screening or Check-in (Day -1).
• Has poor peripheral venous access.
• Has donated or lost 450 mililiter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day 1.
• Has a Screening or Check-in (Day -1) abnormal (clinically significant) ECG. Entry of any participant with an abnormal (not clinically significant) ECG must be approved, and documented by signature by the principal investigator or medically qualified subinvestigator.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Nottingham, United Kingdom

Location

Results Point of Contact

• Title: Takeda
• Organization: Medical Director

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: March 30, 2016
• Study Start: April 28, 2016
• Primary Completion: August 5, 2016
• Study Completion: August 24, 2016
• Last Updated: April 13, 2018
• Results First Posted: April 13, 2018

Record last verified: 2018-04

Locations

GB (1)