Healthy VolunteersPhase 1NCT02485431
Food Effect and Bioavailability of Deflazacort Formulations in Healthy Volunteers
A Phase 1 study testing Deflazacort in people with Healthy Volunteers, run by PTC Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Deflazacort
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Aug 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
- Estimated creatinine clearance < 80 mL/min using Cockcroft-Gault equation.
- QTcF interval > 450 msec at screening.
- Unwilling or unable to consume standardized meals.
- Unwilling or unlikely to comply with the requirements of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, Single-Center, Randomized, Five Period Crossover Study Comparing Food Effect and Bioavailability of Deflazacort Formulations in Healthy Volunteers
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.
Read the detailed description
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 1 of 5 treatment sequences. Each dosing sequence will be enrolled in parallel and will receive all 5 treatments in a crossover fashion.
Subjects will be screened within 28 days of the first dose of study drug. Subjects will check into the clinical pharmacology unit (CPU) on the day prior to dosing (Day -1 for Period 1) and will stay in-house through the 24 hour assessments in each study period. Safety assessments will be performed at screening, check-in for each period, and at 24 hours after each dose per the Schedule of Assessments .Additionally, a safety follow-up phone call will be performed on Day 36 (± 2 days).
Subject participation is expected to last approximately 64 days, including a 28-day screening period and a 36-day on study period (consisting of 5 treatment periods, washout periods lasting 7 days, and the safety follow-up phone call).
- Conditions
- Healthy Volunteers
- Being tested
- Deflazacort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeflazacortDrug
Also called DFZ
| Study group | Role | What they receive |
|---|---|---|
| Deflazacort, fasted | Experimental | 36mg of Deflazacort with 240 ml of room-temperature, non-carbonated water in Fasted state. Receives: 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. Receives: Drug: Deflazacort |
| Deflazacort, crushed, fasted | Experimental | 36mg of Deflazacort crushed and mixed with apple sauce. Receives: Drug: Deflazacort |
| Deflazacort alternate strength,fasted | Experimental | Investigational Formulation Deflazacort tablet (6 X 6mg). Receives: Drug: Deflazacort |
| Deflazacort suspension with apple juice | Experimental | Deflazacort oral suspension (36mg) mixed with 100ml apple juice in fasted state. Receives: Drug: Deflazacort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 30
Secondary outcomes (5)
Treatment emergent AEs and SAEs
Incident of treatment -emergent AEs (TEAEs) and SAEs
Measured: Day 30
Changes from baseline values for lab
Changes from baseline values for clinical laboratory test.
Measured: Day 30
Changes from baseline values for ECG
Changes from baseline values for ECG
Measured: Day 30
Changes from baseline values for physical exam
Changes from baseline values for physical exam
Measured: Day 30
Changes from baseline values for vital signs
Changes from baseline values for vital signs
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- PTC Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON Development Solutions
- Responsible party
- Sponsor
- Investigators
- Uma Arumugam, MD, Study director, ICON Development Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485431
- Sponsor's protocol ID
- MP-104-CL-026
- Status last verified
- Aug 2017
- First submitted
- 24 Jun 2015
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Single-Center, Randomized, Five Period Crossover Study Comparing Food Effect and Bioavailability of Deflazacort Formulations in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02485431
- Acronym / sponsor ID
- MP-104-CL-026
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- PTC TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- ICON Development Solutions
- Study start
- Jun 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 1 of 5 treatment sequences. Each dosing sequence will be enrolled in parallel and will receive all 5 treatments in a crossover fashion.
Subjects will be screened within 28 days of the first dose of study drug. Subjects will check into the clinical pharmacology unit (CPU) on the day prior to dosing (Day -1 for Period 1) and will stay in-house through the 24 hour assessments in each study period. Safety assessments will be performed at screening, check-in for each period, and at 24 hours after each dose per the Schedule of Assessments .Additionally, a safety follow-up phone call will be performed on Day 36 (± 2 days).
Subject participation is expected to last approximately 64 days, including a 28-day screening period and a 36-day on study period (consisting of 5 treatment periods, washout periods lasting 7 days, and the safety follow-up phone call).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Deflazacort, fasted | Experimental | Drug: Deflazacort36mg of Deflazacort with 240 ml of room-temperature, non-carbonated water in Fasted state. |
| Deflazacort, high-fat meal | Experimental | Drug: Deflazacort36mg of Deflazacort with 240 ml of room-temperature, non-carbonated water with high fat meal served 30 minutes prior to dosing. |
| Deflazacort, crushed, fasted | Experimental | Drug: Deflazacort36mg of Deflazacort crushed and mixed with apple sauce. |
| Deflazacort alternate strength,fasted | Experimental | Drug: DeflazacortInvestigational Formulation Deflazacort tablet (6 X 6mg). |
| Deflazacort suspension with apple juice | Experimental | Drug: DeflazacortDeflazacort oral suspension (36mg) mixed with 100ml apple juice in fasted state. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeflazacortAlso: DFZ | Drug | Deflazacort alternate strength,fasted, Deflazacort suspension with apple juice, Deflazacort, crushed, fasted, Deflazacort, fasted, Deflazacort, high-fat meal |
Primary outcome
Pharmacokinetic profile
Time frame: Day 30
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
5 secondary outcomes
Treatment emergent AEs and SAEs
Time frame: Day 30
Changes from baseline values for lab
Time frame: Day 30
Changes from baseline values for ECG
Time frame: Day 30
Changes from baseline values for physical exam
Time frame: Day 30
Changes from baseline values for vital signs
Time frame: Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uma Arumugam, MD study director
ICON Development Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Deflazacort in people with Healthy Volunteers, run by PTC Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic profile (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.