Bioavailability and Effect of Food on TAK-385 Tablet Formulations in Healthy Participants

NCT02396147 | Completed Phase 1 Results

• 2 other identifiers: TAK-385-1010U1111-1165-3720
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the oral bioavailability of two new tablet formulations of TAK-385 (T4 Formulation B and T4 Formulation C) under fasted and fed conditions, relative the T2 Formulation tablet; and to estimate the effect of food on the pharmacokinetics (PK) of a single oral dose of the T4 Formulation B tablet and the T4 Formulation C tablet.

Conditions

Healthy Volunteers

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (3)

• Cmax: Maximum Observed Plasma Concentration for TAK-385

  Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose

• AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose for TAK-385

  Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose

• AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385

  Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose

Secondary Outcomes (7)

• Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From Day 1 to 30 days after the last dose of study drug (Up to 51 days total)

• Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant

  Baseline and Days 4, 10, 14, 20, 24 and 26

• Percentage of Participants With Electrocardiogram (ECG) Parameters Abnormal and Clinically Significant

  Days 1, 11, 21 and 26

• Percentage of Participants With Markedly Abnormal Vital Sign Measurements

  From Day 1 to Day 26

• Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385

  Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose

Study Arms (2)

Arm 1: T2-A + T4B-B + T4B-C

EXPERIMENTAL

T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was a 10-day washout period between each dose.

Drug: TAK-385 T2 Formulation; Drug: TAK-385 T4 Formulation B

Arm 2: T2-A + T4C-D + T4C-E

EXPERIMENTAL

T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was 10-day washout period between each dose.

Drug: TAK-385 T2 Formulation; Drug: TAK-385 T4 Formulation C

Interventions

TAK-385 T2 Formulation DRUG

TAK-385 T2 Formulation tablets

Arm 1: T2-A + T4B-B + T4B-C; Arm 2: T2-A + T4C-D + T4C-E

TAK-385 T4 Formulation B DRUG

TAK-385 T4 Formulation B tablets

Arm 1: T2-A + T4B-B + T4B-C

TAK-385 T4 Formulation C DRUG

TAK-385 T4 Formulation C tablets

Arm 2: T2-A + T4C-D + T4C-E

Eligibility Criteria

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

You may qualify if:

• Age 18 to 55 years, inclusive, at the time of consent.
• Healthy adult male, as determined by a physician evaluation that includes:
• Medical history (ie, no clinically significant medical conditions requiring ongoing drug therapy).
• Physical examination.
• Vital signs.
• Electrocardiogram (ECG).
• Laboratory evaluation (hematology, biochemistry, and urinalysis).
• No acute illness within 30 days before screening that required prescription or over-the-counter (OTC) medicines.
• Weight ≥ 55 kg and body mass index (BMI) between 18.0 and 32.0 kg/m\^2 inclusive, at Screening.
• Nonsmoker for at least 2 years and does not use nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, or nicotine patch or gum).
• Male participants, even if surgically sterilized (ie, status postvasectomy), who:
• Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or
• Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \[eg, calendar, ovulation, symptothermal, postovulation methods for the female partner\] and withdrawal are not acceptable methods of contraception.)
• Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
• Suitable venous access for the study-required blood sampling.

You may not qualify if:

• Has any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
• Has received any investigational compound within 30 days (or 5 half- lives of the compound, if longer) before check-in (Day -1).
• Has received TAK-385 in a previous clinical study.
• Has current or recent (within 6 months) history of gastrointestinal disease that would be expected to influence the absorption of drugs (ie, history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent heartburn, or any surgical intervention).
• Is lactose intolerant.
• Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within 1 year before screening or is unwilling to agree to abstain from alcohol and drugs throughout the study.
• Has a positive test result for hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody at Screening.
• Has a positive urine drug result for drugs of abuse or alcohol at Screening or check-in (Day -1).
• Has taken any prescription medicine or herbal preparations (eg, St. John's wort) or received any immunizations within 30 days before check-in (Day -1).
• Has taken any OTC medications or vitamin supplements within 14 days before check-in (Day -1). Excluded from this list is occasional use of acetaminophen (paracetamol) ≤ 1 g/day or other medication approved by the sponsor on a case-by-case basis.
• Is unwilling to agree to abstain from caffeine and food products from 72 hours before check-in (Day -1) to completion of the study.
• Has a clinically significant electrocardiogram (ECG) abnormality at Screening or check-in (Day -1) or a QTc interval (by the Fridericia correction) of 450 msec or greater. The participant has a history of cardiac disease including, but not limited to, congenital long-QT syndrome, torsades de pointes or torsades de pointes risk factors (eg, cardiac insufficiency, hypokalemia, family history of long-QT syndrome, current use of Class IA \[eg, quinidine or procainamide\] or Class III \[eg, amiodarone or sotalol\] antiarrhythmic medications or other medications with known effects on QT interval).
• Has abnormal laboratory values suggesting a clinically significant disease at Screening or check-in (Day -1) or has abnormalities in the following laboratory parameters: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) value \>1.5 times the upper limit of normal.
• Has engaged in heavy exercise (marathon running, weight lifting, etc) within 72 hours before check-in (Day -1) or is unwilling to agree to abstain from heavy exercise throughout the study.
• Has known allergy to TAK-385 or its excipients.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Tempe, Arizona, United States

Location

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  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: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: March 24, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 25, 2016
• Results First Posted: July 25, 2016

Record last verified: 2016-06

Locations

US (1)