Effects of Rifampin on the Pharmacokinetics of Ataluren

NCT02409004 | Completed Phase 1

• 1 other identifier: PTC124-GD-026-HV
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Drug-drug interaction

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 days

Secondary Outcomes (1)

• Safety as measured by adverse events, laboratory abnormalities, vital signs, and electrocardiogram parameters

  12 days

Study Arms (1)

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

Drug: Ataluren; Drug: Rifampin

Interventions

Ataluren DRUG

Powder for oral suspension (supplied in sachets) 1X 125 mg + 1 x 250 mg + 1000 mg (total of 1375 mg)

Also known as: Ataluren(PTC124)

Ataluren

Rifampin DRUG

Capsule 2x3oo mg Oral

Also known as: Rifadin®

Ataluren

Eligibility Criteria

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

You may qualify if:

• 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 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• PTC Therapeutics: lead

Study Sites (1)

Inventiv

Québec, G1P 0A2, Canada

Location

MeSH Terms

Interventions

ataluren; Rifampin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Oscar Laskin, MD

  PTC Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: April 6, 2015
• Study Start: February 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 22, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)