HealthyPhase 1NCT02409004
Effects of Rifampin on the Pharmacokinetics of Ataluren
A Phase 1 study testing Ataluren and Rifampin in people with Healthy, run by PTC Therapeutics at 1 site in Canada.
Trial summary
This will be a single centre, Phase I, open-label, one cohort, one dose level, fixed-sequence, drug interaction study in healthy volunteers. The objective of this study is to determine the effects of rifampin on the pharmacokinetics of ataluren under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ataluren and Rifampin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to Mar 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, non-smoker (no use of tobacco products within two years prior to screening), ≥18 and ≤55 years of age, with Body Mass Index (BMI) >20.0 and <30.0 kg/m2 and body weight ≥50.0 kg.
- Healthy as defined by:
- the absence of clinically significant illness and surgery within four weeks prior to dosing. Subjects vomiting within 24 hours pre-first dose of ataluren will be carefully evaluated for upcoming illness/disease. Inclusion pre-dosing is at the discretion of the QI;
- the absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease;
- the absence of any known nonsense mutation-mediated disease including Duchenne Muscular Dystrophy.
- Capable of consent.
- Willing to take off dentures at dosing.
- Consent to perform genotyping for UGT1A9
Who cannot join
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
- Positive urine drug screen or urine cotinine test at screening.
- History of allergic reactions to ataluren, rifampin, or other related drugs.
- Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first study drug administration.
- Any reason which, in the opinion of the QI, would prevent the subject from participating in the study.
- Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
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- History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit (more than 14 units of alcohol per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
- History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within three months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], and crack) within one year prior to screening.
- Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days (90 days for biologics) prior to the first dosing or concomitant participation in an investigational study involving no drug administration.
- Use of medication other than topical products without significant systemic absorption:
- prescription medication within 14 days prior to the first dosing;
- over-the-counter products including natural health products (eg, food supplements and herbal supplements) within seven days prior to the first ataluren dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily);
- a depot injection or an implant of any drug within three months prior to the first dosing.
- Donation of plasma within seven days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing.
- Hemoglobin <128 g/L and hematocrit <0.37 L/L at screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study Assessing the Effects of Rifampin on the Pharmacokinetics of Ataluren in Healthy Subjects
This will be a single centre, Phase I, open-label, one cohort, one dose level, fixed-sequence, drug interaction study in healthy volunteers. The objective of this study is to determine the effects of rifampin on the pharmacokinetics of ataluren under fasting conditions.
Read the detailed description
A total of 15 healthy, adult, male non-smokers, were included in this study. Subjects were administered ataluren on Day 1 followed by rifampin from Days 3 to12, and again ataluren on Day 11. On Day 11, ataluren was administered before rifampin administration.
Prior to entering the trial, subjects had a screening visit to establish eligibility within 28 days before study drug administration. Subjects were confined from at least10 hours before the first ataluren dosing on Day 1 until approximately 50 hours postdose(Day 3). Thereafter, subjects came back every morning from Days 4 to 10 for rifampin dosing. Then, subjects reported to the clinical site at least 10 hours before ataluren dosing on Day 11 (evening of Day 10) and remained in the clinical site until after 50 hours post-Day 11 ataluren dose (Day 13).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtalurenDrug
Also called Ataluren(PTC124)
Powder for oral suspension (supplied in sachets) 1X 125 mg + 1 x 250 mg + 1000 mg (total of 1375 mg)
RifampinDrug
Also called Rifadin®
Capsule 2x3oo mg Oral
| Study group | Role | What they receive |
|---|---|---|
| Ataluren | Experimental | Ataluren 1375 mg powder for oral suspension administered once daily on Days 1 and 11 Rifampin 300 mg capsules administered twice daily on Day 3 to Day 12 Receives: Drug: Ataluren; Drug: Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC)
The objective of this study is to determine the effects of rifampin on the pharmacokinetics of ataluren under fasting conditions.
Measured: 12 days
Maximum plasma concentration (Cmax)
The objective of this study is to determine the effects of rifampin on the pharmacokinetics of ataluren under fasting conditions.
Measured: 12 days
Secondary outcomes (1)
Safety as measured by adverse events, laboratory abnormalities, vital signs, and electrocardiogram parameters
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- PTC Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oscar Laskin, MD, Study director, PTC Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409004
- Sponsor's protocol ID
- PTC124-GD-026-HV
- Status last verified
- Dec 2017
- First submitted
- 24 Mar 2015
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Assessing the Effects of Rifampin on the Pharmacokinetics of Ataluren in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02409004
- Acronym / sponsor ID
- PTC124-GD-026-HV
- Conditions
- Healthy
- Keywords
- Drug-drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- PTC TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 Apr 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 will be a single centre, Phase I, open-label, one cohort, one dose level, fixed-sequence, drug interaction study in healthy volunteers. The objective of this study is to determine the effects of rifampin on the pharmacokinetics of ataluren under fasting conditions.
Detailed description
A total of 15 healthy, adult, male non-smokers, were included in this study. Subjects were administered ataluren on Day 1 followed by rifampin from Days 3 to12, and again ataluren on Day 11. On Day 11, ataluren was administered before rifampin administration.
Prior to entering the trial, subjects had a screening visit to establish eligibility within 28 days before study drug administration. Subjects were confined from at least10 hours before the first ataluren dosing on Day 1 until approximately 50 hours postdose(Day 3). Thereafter, subjects came back every morning from Days 4 to 10 for rifampin dosing. Then, subjects reported to the clinical site at least 10 hours before ataluren dosing on Day 11 (evening of Day 10) and remained in the clinical site until after 50 hours post-Day 11 ataluren dose (Day 13).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ataluren | Experimental | Drug: Ataluren, Drug: RifampinAtaluren 1375 mg powder for oral suspension administered once daily on Days 1 and 11 Rifampin 300 mg capsules administered twice daily on Day 3 to Day 12 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male, non-smoker (no use of tobacco products within two years prior to screening), ≥18 and ≤55 years of age, with Body Mass Index (BMI) >20.0 and <30.0 kg/m2 and body weight ≥50.0 kg.
- Healthy as defined by:
- Capable of consent.
- Willing to take off dentures at dosing.
- Consent to perform genotyping for UGT1A9
Key exclusion criteria (15 listed)
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
- Positive urine drug screen or urine cotinine test at screening.
- History of allergic reactions to ataluren, rifampin, or other related drugs.
- Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first study drug administration.
- Any reason which, in the opinion of the QI, would prevent the subject from participating in 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 |
|---|---|---|
| AtalurenAlso: Ataluren(PTC124)Powder for oral suspension (supplied in sachets) 1X 125 mg + 1 x 250 mg + 1000 mg (total of 1375 mg) | Drug | Ataluren |
| RifampinAlso: Rifadin®Capsule 2x3oo mg Oral | Drug | Ataluren |
Primary outcome
Area under the plasma concentration versus time curve (AUC)
Time frame: 12 days
The objective of this study is to determine the effects of rifampin on the pharmacokinetics of ataluren under fasting conditions.
Maximum plasma concentration (Cmax)
Time frame: 12 days
The objective of this study is to determine the effects of rifampin on the pharmacokinetics of ataluren under fasting conditions.
1 secondary outcome
Safety as measured by adverse events, laboratory abnormalities, vital signs, and electrocardiogram parameters
Time frame: 12 days
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 22 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Oscar Laskin, MD study director
PTC Therapeutics
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 Ataluren and Rifampin in people with Healthy, run by PTC Therapeutics at 1 site in Canada.
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 8 inclusion and 15 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 22 Dec 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 Canada. 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?
Area under the plasma concentration versus time curve (AUC) (time frame: 12 days). The study lists 2 primary outcomes in all. 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 22 Dec 2017.