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Trial record 27 of 389 for:    CLARITHROMYCIN

Evaluate Effects of Multiple Doses of Rifampin and Clarithromycin on the Single Dose Pharmacokinetics of Deflazacort

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ClinicalTrials.gov Identifier: NCT02286635
Recruitment Status : Completed
First Posted : November 10, 2014
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
PTC Therapeutics

Brief Summary:
The primary objective of the study is to determine the potential effects of multiple doses of rifampin and clarithromycin on the single dose pharmacokinetics (PK) of the deflazacort active metabolite (21 desacetyl-DFZ) in healthy adult subjects.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Deflazacort and rifampin Drug: Deflazacort and Clarithromycin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, 2-Arm, Fixed-Sequence Study to Evaluate the Potential Effects of Multiple Doses of Rifampin (CYP3A4 Inducer) and Clarithromycin (CYP3A4 Inhibitor) on the Single Dose Pharmacokinetics of Deflazacort in Healthy Subjects
Study Start Date : November 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

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Arm Intervention/treatment
Experimental: Cohort A Deflazacort and Rifampin
Subjects will recieve one 18 mg dose of deflazacort on Day 1, Period 1 and Day 10, Period 2; cohort A. Subjects will receive once daily dosing of rifampin on Day 1, Period 2 through Day 10, Period 2.
Drug: Deflazacort and rifampin
Deflazacort, a glucocorticoid with anti-inflammatory and immunosuppressive effects, is used in treating a variety of diseases. Pharmacologically it is an inactive pro-drug which is metabolized completely and rapidly to the active drug 21-desacetyldeflazacort (21 desacetyl-DFZ). The elimination of this metabolite is primarily via the urine in humans. Its potency is approximately 70 to 90% of prednisone and 6 mg of deflazacort has approximately the same anti-inflammatory potency as 5 mg of prednisolone or prednisone. Rifampin is a potent inducer of drug metabolism by inducing a variety of hepatic and intestinal CYP enzymes, especially CYP3A4. Rifampin is a semi-synthetic antibiotic.
Other Name: DFZ

Experimental: Cohort B Deflazacort and Clarithromycin
Subjects will recieve one 18 mg dose of deflazacort on Day 1, Period 1 and Day 4, period 2; cohort B. Subjects will receive twice daily dosing of clarithromycin on Day 1, Period 2 through Day 4, Period 2.
Drug: Deflazacort and Clarithromycin
Deflazacort, a glucocorticoid with anti-inflammatory and immunosuppressive effects. It is an inactive pro-drug which is metabolized completely and rapidly to the active drug 21 desacetyl-DFZ. The elimination of this metabolite is primarily via the urine in humans. Its potency is approximately 70 to 90% of prednisone. Clarithromycin is a semi-synthetic macrolide antibiotic. Clarithromycin is active in vitro against a variety of aerobic and anaerobic gram-positive and gram-negative bacteria as well as most mycobacterium avium complex (MAC) bacteria. Additionally, the 14-OH clarithromycin metabolite also has clinically significant antimicrobial activity. Clarithromycin is indicated for the treatment of mild to moderate infections such as pharyngitis/tonsillitis.
Other Name: biaxin




Primary Outcome Measures :
  1. Effects of CYP3A4 inhibitors and inducers on the pharmacokinetics (PK) of deflazacort in healthy subjects including the area under the plasma concentration time curve, from time 0 to the last measurable non-zero concentration. [ Time Frame: 10 days and 4 days ]
    Effects of CYP3A4 inhibitors and inducers on the pharmacokinetics (PK) of deflazacort in healthy subjects including the area under the plasma concentration time curve, from time 0 to the last measurable non-zero concentration.


Secondary Outcome Measures :
  1. Safety and tolerability of one dose of deflazacort in healthy subjects receiving CYP3A4 inhibitors and inducers as measured by capturing occurrence of adverse events. [ Time Frame: 10 days and 4 days ]
    Safety and tolerability of one dose of deflazacort in healthy subjects receiving CYP3A4 inhibitors and inducers as measured by capturing occurrence of adverse events.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, adult, male or female, 18 55 years of age
  • Continuous non smoker who has not used nicotine containing products for at least 3 months
  • Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2
  • For a female of non childbearing potential: must have undergone a sterilization procedures or be postmenopausal with amenorrhea for at least 1 year prior to the first dose of study drug and FSH serum levels consistent with postmenopausal status
  • A non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days
  • If male, must agree not to donate sperm from the first dose of study drug until 90 days

Exclusion Criteria:

  • Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study
  • History or presence of alcoholism or drug abuse within the past 2 years
  • History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds (e.g., steroids or their formulations including lactose)
  • History or presence of:

    1. Symptomatic cardiomyopathy at screening
    2. Immunosuppression or other contraindications for corticosteroid treatment
    3. History of chronic systemic fungal or viral infections
    4. Galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
    5. Diabetes mellitus
    6. Osteoporosis
    7. Myasthenia gravis
    8. Epilepsy
    9. Idiopathic hypocalcuria
    10. Hypothyroidism (TSH clinically significant)
    11. Gastrointestinal issues or ulcers
    12. Previous corticoids-induced myopathy
    13. Ocular herpes simplex
  • Female subjects of childbearing potential
  • Female subjects who are pregnant or lactating
  • Positive urine drug or alcohol results
  • Positive urine cotinine
  • Positive results for HIV, HBsAg or HCV
  • Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg
  • Seated heart rate is lower than 40 bpm or higher than 99 bpm
  • QTc interval is > 430 msec (males) or > 450 msec (females)
  • Has received any live or live-attenuated vaccine within 30 days
  • Has received any immunosuppressive agents, coal tar, and/or radiation therapies within 30 days
  • Has received injectable corticoids in the 12 weeks dose of study drug or any oral form of corticoids in 30 days
  • Estimated creatinine clearance < 80 ml/min
  • Unable to refrain from or anticipates the use of

    • Any drug, including prescription and non prescription medications, as well as herbal remedies known to be significant inhibitors of CYP 3A4 enzymes and/or P gp for 14 days
    • Any drugs known to be significant inducers of CYP 3A4 enzymes and/or P gp, including St. John's Wort, for 28 days
  • Have been on a diet incompatible with the on study diet within 28 days
  • Donation of blood or significant blood loss within 56 days
  • Plasma donation within 7 days
  • Participation in another clinical trial within 28 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02286635


Locations
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United States, Arizona
Celerion
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
PTC Therapeutics
Investigators
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Study Director: Bioscience Center Marathon Pharmaceuticals, LLC

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Responsible Party: PTC Therapeutics
ClinicalTrials.gov Identifier: NCT02286635     History of Changes
Other Study ID Numbers: MP-104-CL-025
First Posted: November 10, 2014    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Clarithromycin
Rifampin
Deflazacort
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Anti-Inflammatory Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs