Food Effect and Bioavailability of Deflazacort Formulations in Healthy Volunteers

NCT02485431 | Completed Phase 1

• 1 other identifier: MP-104-CL-026
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, single-center, single-dose, randomized, 5-period crossover study designed to assess the comparative bioavailability and food effect of deflazacort. A total of 45 subjects will be randomly assigned to receive 1 of 5 treatment sequences. Each dosing sequence will be enrolled in parallel and all subjects will receive all 5 treatments in a crossover fashion.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic profile

  Pharmacokinetic parameters such as the maximum observed plasma concentration (Cmax), time to Cmax (Tmax), the area under the plasma concentration versus time curve from time 0 (predose) to the last quantifiable time point (AUClast), AUC from time 0 (predose) to time infinity (AUCinf), the elimination rate constant (λz), and terminal elimination half-life (t½) will be calculated

  Day 30

Secondary Outcomes (5)

• Treatment emergent AEs and SAEs

  Day 30

• Changes from baseline values for lab

  Day 30

• Changes from baseline values for ECG

  Day 30

• Changes from baseline values for physical exam

  Day 30

• Changes from baseline values for vital signs

  Day 30

Study Arms (5)

Deflazacort, fasted

EXPERIMENTAL

36mg of Deflazacort with 240 ml of room-temperature, non-carbonated water in Fasted state.

Drug: Deflazacort

Deflazacort, high-fat meal

EXPERIMENTAL

36mg of Deflazacort with 240 ml of room-temperature, non-carbonated water with high fat meal served 30 minutes prior to dosing.

Drug: Deflazacort

Deflazacort, crushed, fasted

EXPERIMENTAL

36mg of Deflazacort crushed and mixed with apple sauce.

Drug: Deflazacort

Deflazacort alternate strength,fasted

EXPERIMENTAL

Investigational Formulation Deflazacort tablet (6 X 6mg).

Drug: Deflazacort

Deflazacort suspension with apple juice

EXPERIMENTAL

Deflazacort oral suspension (36mg) mixed with 100ml apple juice in fasted state.

Drug: Deflazacort

Interventions

Deflazacort DRUG

Also known as: DFZ

Deflazacort alternate strength,fasted; Deflazacort suspension with apple juice; Deflazacort, crushed, fasted; Deflazacort, fasted; Deflazacort, high-fat meal

Eligibility Criteria

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

You may qualify if:

• Healthy males and females ≥ 18 and ≤ 55 at the time of screening.
• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2, inclusive, at screening and Day -1.
• Women of nonchildbearing potential, defined as tubal ligation, hysterectomy, postmenopausal (amenorrhea for \> 1 year; confirmed by FSH), or oophorectomy.
• Males who are sexually active and whose partners are females of childbearing potential must agree to use condoms from screening through 90 days after the last dose of study drug.
• Males must agree to not donate sperm from screening through 90 days after the last dose of study drug.
• Subjects must be healthy and without clinically significant abnormalities as assessed by review of medical and surgical history, physical examination, vital signs measurement, electrocardiogram (ECG), and laboratory evaluations conducted at the screening visit and on CPU admission.
• Subjects must be nonsmokers, defined as having abstained from tobacco- or nicotine-containing products (eg, cigarettes, chewing tobacco, snuff, nicotine patches, and electronic cigarettes) in the 3 months prior to screening.

You may not qualify if:

• Positive pregnancy test or lactating.
• History or presence of conditions which, in the judgment of the investigator, are known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
• History or presence of conditions that may place the subject at increased risk as determined by the investigator.
• History of presence of hypersensitivity of idiosyncratic reaction to the study drugs or related compounds (eg, steroids or their formulations including lactose).
• History of surgery or major trauma within 12 weeks of screening, or surgery planned during the study.
• History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of screening.
• Use of prescription medications within 14 days or any drugs that inhibit study drug specific cytochrome P450(s) within 14 days or any drugs that induce specific cytochrome P450s, including St. John's Wort, within 28 days, or 5 half-lives, whichever is longer, of administration of the first dose of study drug and throughout the study.
• Use of over the-counter (OTC) drugs (including herbal preparations) within 7 days or 5 half-lives, whichever is longer, prior to administration of the first dose of study drug and throughout the study.
• Has taken other investigational drugs, including deflazacort or related compounds, or participated in any clinical study within 30 days or 5 half-lives of the investigational drug's PK, pharmacodynamic, or biological activity, whichever is longer, prior to first dose of study drug in this study.
• Has received any immunosuppressive agents, coal tar, and/or radiation therapies within 30 days prior to the first dose of study drug.
• Has received injectable corticoids in the 12 weeks prior to the first dose of study drug or any oral form of corticoids in the 30 days prior to the first dose of study drug.
• Has received any live or live-attenuated vaccine within 30 days prior to the first dose of study drug and/or intends to receive one on study.
• Significant blood loss (\> 450 mL) or has donated 1 or more units of blood or plasma within 6 weeks prior to study participation.
• Positive urine drugs of abuse, alcohol breath test, or urine cotinine screen.
• Positive screen for human immunodeficiency virus (HIV)-1 and HIV-2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody.

Sponsors & Collaborators

• PTC Therapeutics: lead
• ICON Development Solutions: collaborator

Study Sites (1)

ICON Early Phase Services

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Interventions

deflazacort

Study Officials

• Uma Arumugam, MD

  ICON Development Solutions, LLC

  STUDY DIRECTOR

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: June 24, 2015
• First Posted: June 30, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

US (1)