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Trial record 5 of 9 for:    rg1662

A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RG1662 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02470832
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : August 26, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
The study is being conducted to investigate the effect of itraconazole treatment in the pharmacokinetics of RG1662. It is also to evaluate the exposure of RG1662 vs. QTc response relationship and the safety and tolerability of RG1662 when given in combination with itraconazole in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Patient Study Drug: RG1662 Drug: itraconazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combination therapy RG1662 + itraconazole
Days 20-29: Oral administration RG1662 twice daily within 30 minutes of a meal + 2 x 100 mg itraconazole once daily with food
Drug: RG1662
Drug: itraconazole
Experimental: RG1662 Monotherapy
Days 1-10: RG1662 120 mg twice daily (b.i.d.) within 30 minutes of a meal for 10 days (Days 1 to 9, Day 10 only a.m. dose). (Cohort A subjects will receive 1 x 120 mg RG1662 tablets twice daily. In Cohorts B and C the dose of RG1662 will be decided upon following review of the interim safety and pharmacokinetic data of the 4 subjects in Cohort A.)
Drug: RG1662
Experimental: itraconazole Monotherapy
Days 15-19: 200 mg of itraconazole twice daily for 5 days (Days 15 to 18, Day 19 only a.m. dose)
Drug: itraconazole



Primary Outcome Measures :
  1. Area under the plasma concentration-time curve from 0-t (AUC0-t) [ Time Frame: Within 29 days ]
  2. Maximum observed plasma concentration (Cmax) [ Time Frame: Within 29 days ]
  3. Time to maximum observed plasma concentration (Tmax) [ Time Frame: Within 29 days ]

Secondary Outcome Measures :
  1. Change from baseline in QTcF [ Time Frame: Up to 29 days ]
  2. Incidence of adverse events [ Time Frame: Within 43 days ]
  3. Clinically significant changes from baseline in physical examination or laboratory parameters [ Time Frame: Within 29 days ]
  4. Mean model parameters of RG1662 concentration vs. QTcF changes [ Time Frame: Within 29 days ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female volunteers
  • Ages 18 to 60 years, inclusive
  • A body mass index (BMI) between 18 to 32 kg/m2, inclusive
  • Agreement to comply with study restrictions

Exclusion Criteria:

  • History of epilepsy, convulsions or significant head injury or electroencephalogram (EEG) abnormalities
  • Electrocardiogram (EGC) or vital signs abnormalities
  • Significant history of drug allergy, as determined by the Investigator, or a known hypersensitivity to any of the ingredients of any of the study treatments
  • Use of any drugs or substances that are known to be substrates, inducers or inhibitors of CYP3A4 within 30 days of the first dose administration
  • Pregnant or lactating
  • Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions

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): NCT02470832


Locations
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United Kingdom
Leeds, United Kingdom, LS2 9LH
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02470832     History of Changes
Other Study ID Numbers: WP29402
2015-000261-31 ( EudraCT Number )
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
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