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Evaluate the Effects of Itraconazole and Ciprofloxacin on Single-Dose PK of Pracinostat in Healthy Nonsmoking Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02118909
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Helsinn Healthcare SA

Brief Summary:
This study is designed as a 2-part, open-label study to assess the effect of pracinostat with itraconazole (part 1) and pracinostat with ciprofloxacin (part 2) on the bioavailability of pracinostat. Secondarily to evaluate the safety and tolerability of pracinostat administered with itraconazole or ciprofloxacin.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Non-smokers Drug: Pracinostat Drug: Itraconazole Drug: Ciprofloxacin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Two-Part Study to Evaluate the Effect of CYP3A4 Inhibition (Itraconazole-Part 1) and CYP1A2 Inhibition (Ciprofloxacin - Part 2) on the Single-Dose Pharmacokinetics of Pracinostat in Healthy Nonsmoking Subjects
Study Start Date : May 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Part 1 (Pracinostat + Itraconazole)
Single-dose pracinostat and itraconazole dosing every day for 8 days
Drug: Pracinostat
Drug: Ciprofloxacin
Experimental: Part 2 (Pracinostat + Ciprofloxacin)
Single dose pracinostat and ciprofloxacin 2 times a day for 7 days
Drug: Pracinostat
Drug: Itraconazole

Primary Outcome Measures :
  1. Peak plasma concentration Cmax in healthy nonsmoking subjects given a single-dose of pracinostat [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours ]
    Plasma PK parameter Cmax to describe bioavailability of pracinostat

Secondary Outcome Measures :
  1. Number of participants with Adverse Events as a measure of safety and tolerability of single-dose pracinostat when administered with itraconazole or with ciprofloxacin in healthy nonsmoking adult subjects. [ Time Frame: 1 month ]
    Safety will be monitored through physical examinations, vital sign measurements, electrocardiograms, adverse events, and clinical laboratory tests.

  2. Peak plasma PK concentration Area Under the Curve (AUC)AUC 0-t, AUC 0-inf in healthy nonsmoking subjects given a single dose of pracinostat [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours ]
    Plasma PK parameter AUC 0-t, AUC 0-inf for pracinostat

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy volunteer
  • Continuous nonsmoker who has not used nicotine-containing products for at least 3 months prior to the first dose
  • Body Mass Index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
  • Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI.
  • Female subjects must be of non-childbearing potential and must have undergone sterilization procedures at least 6 months prior to the first dose or be postmenopausal with amenorrhea for at least 1 year prior to the first dose and follicle stimulating hormone (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 beyond the last dose of study medication.
  • Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion Criteria:

  • Subject is mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study.
  • History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
  • History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
  • History or presence of alcoholism or drug abuse within the past 2 years prior to screening.
  • History or presence of hypersensitivity or idiosyncratic reaction to the study medication or related compounds.
  • History of prolonged QT syndrome or require any current medications which may prolong QTc.
  • History or presence of:

    • myasthenia gravis;
    • convulsions.
  • Female subjects who are pregnant or lactating.
  • Positive urine cotinine, drug and alcohol results at screening or check-in.
  • Positive results at screening for HIV, HBsAg or HCV.
  • Seated blood pressure is less than 90/40 mgHg or greater than 140/90 mmHg at screening.
  • Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening.
  • QTcF interval, is >430 msec (males) or >450 msec (females) or deemed clinical abnormal by the PI at screening or prior to dosing.
  • Unable to refrain from or anticipates the use of:

    • Any drug, including prescription and non-prescription medications, tobacco, antacids, herbal remedies, or vitamin supplements beginning approximately 14 days prior to the first dose of study medication and throughout the study. Hormone replacement therapy will be allowed if postmenopausal females are on a stable treatment for at least 1 month prior to dosing on Day 1 of Period 1. Acetaminophen (up to 2 g per 24 hour period) may be permitted during the study.
    • Any drugs known to be significant inducers of CYP enzymes, including St. John's Wort, for 28 days prior to the first dose of study medication and throughout the study. Appropriate sources will be consulted by the PI or designee to confirm lack of PK/pharmacodynamics interaction with study medication.
  • Have been on a diet incompatible with the on-study diet, in the opinion of the PI, within the 28 days prior to the first dose of study medication(s), and throughout the study.
  • Hemoglobin, platelet count or absolute neutrophils below the lower limit of normal at screening.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) above upper limit of normal at screening.
  • Donation of blood or significant blood loss within 56 days prior to the first dose of study medication.
  • Participation in another clinical trial within 28 days prior to the first dose of study medication.

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 identifier (NCT number): NCT02118909

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United States, Arizona
Tempe, Arizona, United States, 67296
Sponsors and Collaborators
Helsinn Healthcare SA
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Principal Investigator: Terry E O'Reilly, MD Celerion
Additional Information:
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Responsible Party: Helsinn Healthcare SA Identifier: NCT02118909    
Other Study ID Numbers: MEI-007
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antifungal Agents
14-alpha Demethylase Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors