A Bioequivalence Study of the Lu AA21004 20 mg and 2×10 mg Tablets

NCT03437564 | Completed Phase 1 Results

• 3 other identifiers: Vortioxetine-1001U1111-1208-2715JapicCTI-183863
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the bioequivalence of a single oral administration of a vortioxetine (Lu AA21004) 20 mg tablet in comparison with two of vortioxetine 10 mg tablets in Japanese healthy adult participants.

Conditions

Healthy Adult Participants

Outcome Measures

Primary Outcomes (2)

• AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Time Point of Unchanged Lu AA21004

  Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

• Cmax: Maximum Plasma Concentration (Observed Value) of Unchanged Lu AA21004

  Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Secondary Outcomes (10)

• AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Unchanged Lu AA21004

  Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

• Tmax: Time to Reach Cmax (Observed Value) of Unchanged Lu AA21004

  Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

• MRT∞, ev: Mean Residence Time 0 to Infinity of Unchanged Lu AA21004

  Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

• MRTlast, ev: Mean Residence Time From Time 0 to the Time of the Last Quantifiable Concentration of Unchanged Lu AA21004

  Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

• λz: Apparent Elimination Rate Constant of Unchanged Lu AA21004

  Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Study Arms (2)

Vortioxetine one 20 mg tablet + two 10 mg tablets

EXPERIMENTAL

Vortioxetine 20 mg (one 20 mg tablet) on Day 1 in Period 1 in a fasted state + vortioxetine 20 mg (two 10 mg tablets) on Day 1 in Period 2 in a fasted state.

Drug: Vortioxetine

Vortioxetine two 10 mg tablets + one 20 mg tablet

EXPERIMENTAL

Vortioxetine 20 mg (two 10 mg tablets) on Day 1 in Period 1 in a fasted state + vortioxetine 20 mg (one 20 mg tablet) on Day 1 in Period 2 in a fasted state.

Drug: Vortioxetine

Interventions

Vortioxetine DRUG

Vortioxetine tablet

Also known as: Lu AA21004

Vortioxetine one 20 mg tablet + two 10 mg tablets; Vortioxetine two 10 mg tablets + one 20 mg tablet

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be a healthy Japanese adult volunteer.
• Understand the contents of the study and is capable of providing written consent to participate in the study.
• Be willing to comply with all study procedures and restrictions.
• Aged between ≥20 and ≤45 years at the time of screening.
• Have a BMI of ≥18.5 and ≤24.9 (kg/m\^2) and a body weight of ≥50 kg at the time of screening.
• Be a extensive metabolizer (EM) based on CYP2D6 genotyping at the time of screening.
• A female participant of childbearing potential with a non-sterilized male partner must agree to routinely use appropriate contraception during the study from the time of signing informed consent until 4 weeks after last dosing of the study drug.

You may not qualify if:

• Has received any investigational drug within 90 days before screening for this study.
• Previously received Lu AA21004 before participation in this study.
• Is an employee of the sponsor or the study site, or immediate family member, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or who may be coerced to provide consent.
• Has uncontrolled, clinically relevant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may affect study participation or study results.
• Has a history of multiple episodes or severe allergies (eg, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription drugs, over the counter (OTC) drugs, or foods.
• Has a positive pregnancy test at the time of screening or Day -1.
• Is a pregnant or lactating female.
• Has a positive urine drug screen test at the time of screening or Day -1.
• Has a history of drug abuse (defined as any illicit drug use) or has a history of alcohol dependence within 2 years before the start of screening or is unwilling to agree to abstain from alcohol and drugs throughout the study.
• Consumes 6 or more servings of caffeinated beverages (containing about 120 mg of caffeine per serving) such as of coffee, tea, cola, or energy drinks.
• Is a smoker who smoked cigarettes or used nicotine-containing products (such as nicotine patch) within 6 months before the Period 1 study drug administration.
• Used any of the excluded drugs, dietary products or foods during the specified time periods, or will need any of them during the study period.
• Has any current or recent gastrointestinal diseases that would be expected to influence the absorption of drugs (ie, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent \[more than once per week\] occurrence of heartburn), or any surgical intervention (Stomach, cholecystectomy etc.).
• Has a history of cancer.
• Has a positive test result for any of the following at the time of screening: hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen, serological test for syphilis.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Nishi Kumamoto Hospital

Kumamoto, Japan

Location

MeSH Terms

Interventions

Vortioxetine

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study 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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 19, 2018
• Study Start: February 16, 2018
• Primary Completion: April 13, 2018
• Study Completion: April 13, 2018
• Last Updated: June 27, 2019
• Results First Posted: June 26, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)