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Trial record 15 of 205 for:    SPORANOX I.V. OR ITRACONAZOLE OR ONMEL OR SPORANOX-PULSE OR Sporanos OR R 51,211 OR SPORANOX

Food-effect, Drug-Drug Interaction (DDI), and Formulation Bridging Study

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ClinicalTrials.gov Identifier: NCT03555617
Recruitment Status : Completed
First Posted : June 13, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

Brief Summary:
This is a Phase 1, open-label, 2-cohort, food-effect, DDI, and formulation bridging study.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Drug: TD-1473 Drug: Itraconazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, Open-Label, 2-Cohort Study to Assess the Single Dose Pharmacokinetics of Two Formulations of TD-1473 and to Assess the Effect of a High-Fat Meal and Itraconazole on the Pharmacokinetics of TD-1473 in Healthy Subjects
Actual Study Start Date : June 13, 2018
Actual Primary Completion Date : July 15, 2018
Actual Study Completion Date : July 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TD-1473 formulation bridging & food effect
Subjects will receive, on Day 1 of each period, a single 100 mg oral dose of the tablet formulation of TD-1473 in the fed or fasted state, or the PIC formulation of TD-1473 in the fasted state, as part of a 3-period, crossover design.
Drug: TD-1473
oral capsule/tablet, QD

Experimental: TD-1473 with Itraconazole
Subjects will receive a single 100 mg oral dose of the tablet formulation of TD-1473 in the fasted state on Day 1 of Period 1. In Period 2, subjects will receive, in the fasted state, single oral doses of 200 mg itraconazole solution on Days -4 through 7 for a total of 11 days, with a single 100 mg oral dose of the tablet formulation of TD-1473 co-administered on Day 1.
Drug: TD-1473
oral capsule/tablet, QD

Drug: Itraconazole
oral solution, QD

Experimental: TD-1473 without Itraconazole
Subjects will receive a single 100 mg oral dose of the tablet formulation of TD-1473 in the fasted state on Day 1 of Period 1.
Drug: TD-1473
oral capsule/tablet, QD




Primary Outcome Measures :
  1. Maximum observed concentration (Cmax) in Plasma [ Time Frame: Up to 8 days post-dose ]
  2. Time to maximum observed concentration (tmax) in Plasma [ Time Frame: Up to 8 days post-dose ]
  3. Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma [ Time Frame: Up to 8 days post-dose ]
  4. Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma [ Time Frame: Up to 8 days post-dose ]
  5. Apparent terminal elimination half-life (t1/2) in Plasma [ Time Frame: Up to 8 days post-dose ]
  6. Apparent clearance (Cl/F) in Plasma [ Time Frame: Up to 8 days post-dose ]
  7. Apparent volume of distribution (Vz/F) in Plasma [ Time Frame: Up to 8 days post-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female between 18 to 55 years old
  • Male subjects must abstain from sexual intercourse or use a highly effective method of birth control
  • Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control
  • Body Mass Index (BMI) 18 to 32 kg/m2
  • Willing and able to give informed consent
  • Additional inclusion criteria apply

Exclusion Criteria:

  • Planning to conceive a child during the study or within 2 months after the last dose of study drug
  • Is positive for hepatitis A, B or C, and/or HIV
  • Has clinically significant abnormalities in baseline laboratory evaluations
  • Subject has a clinically significant abnormal electrocardiogram (ECG)
  • Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening or is currently participating in another trial of an investigational drug (or medical device)
  • Additional exclusion criteria apply

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): NCT03555617


Locations
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United States, Nebraska
Celerion
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Theravance Biopharma
Investigators
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Study Director: Nathan Pfiefer, PharmD, PhD Theravance Biopharma

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Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT03555617     History of Changes
Other Study ID Numbers: 0174
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Theravance Biopharma:
healthy volunteers
drug-drug interaction
itraconazole
CYP3A
P-gp
Inflammatory Bowel Disease
IBD
Irritable Bowel Syndrome
IBS

Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors