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A 2 Part Study to Assess the Relative Bioavailability of Tablet Formulation Compared to Capsule Formulation and the Effect of Food and Taste Assessment on the Tablet Formulation in Healthy Participants

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ClinicalTrials.gov Identifier: NCT03847987
Recruitment Status : Completed
First Posted : February 20, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is a two-part, open-label, healthy volunteer study. Part I will investigate the relative bioavailability of capsule and tablet formulations of RO7017773. Part II will explore how the taste of the tablet formulation is perceived with and without added sweetener/flavoring.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: RO7017773 Phase I Capsule Drug: RO7017773 Phase II Tablet Unflavored Drug: RO7017773 Phase II Tablet Sweetened/Flavored Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 2 Part, Randomized, Open-Label, Single Dose, Crossover Study to Assess the Relative Bioavailability of Phase II Tablet Formulation Compared to the Current Phase I Capsule Formulation and the Effect of Food and Taste Assessment on the Phase II Tablet Formulation in Healthy Participants
Actual Study Start Date : March 12, 2019
Actual Primary Completion Date : April 22, 2019
Actual Study Completion Date : April 22, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1
Participants will receive 4 single oral doses of RO7017773 under either fed or fasted conditions, one of which will be a taste assessment. There will be a 7-10 day washout period between doses.
Drug: RO7017773 Phase I Capsule
Participants will receive 1 single oral dose of RO7017773 Phase I Capsule.

Drug: RO7017773 Phase II Tablet Unflavored
Participants will receive 3 single oral doses of unflavored RO7017773 Phase II tablet during Part 1, and 1 single oral dose of unflavored RO7017773 Phase II tablet during Part 2.

Experimental: Part 2
Participants will receive 2 single oral doses of RO7017773, either sweetened/flavored, or unflavored and dispersed in juice. There will be a 7-10 day washout period between doses.
Drug: RO7017773 Phase II Tablet Unflavored
Participants will receive 3 single oral doses of unflavored RO7017773 Phase II tablet during Part 1, and 1 single oral dose of unflavored RO7017773 Phase II tablet during Part 2.

Drug: RO7017773 Phase II Tablet Sweetened/Flavored
Participants will receive 1 single oral dose of sweetened/flavored RO7017773 Phase II tablet during Part 2.




Primary Outcome Measures :
  1. Time to Maximum Plasma Concentration (Tmax) of RO7017773 [ Time Frame: At pre-defined intervals from Day 1 to Day 5 ]
  2. Maximum Observed Plasma Concentration (Cmax) of RO7017773 [ Time Frame: At pre-defined intervals from Day 1 to Day 5 ]
  3. Area Under the Concentration-Time Curve (AUC) of RO7017773 [ Time Frame: At pre-defined intervals from Day 1 to Day 5 ]
  4. Apparent Terminal Half-Life (T1/2) of RO7017773 [ Time Frame: At pre-defined intervals from Day 1 to Day 5 ]
  5. Apparent Oral Clearance (CL/F) of RO7017773 [ Time Frame: At pre-defined intervals from Day 1 to Day 5 ]
  6. Taste Assessment, as Measured by Taste Questionnaire [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Tmax of RO7017773 [ Time Frame: At pre-defined intervals from Day 1 to Day 5 ]
  2. Cmax of RO7017773 [ Time Frame: At pre-defined intervals from Day 1 to Day 5 ]
  3. AUC of RO7017773 [ Time Frame: At pre-defined intervals from Day 1 to Day 5 ]
  4. T1/2 of RO7017773 [ Time Frame: At pre-defined intervals from Day 1 to Day 5 ]
  5. CL/F of RO7017773 [ Time Frame: At pre-defined intervals from Day 1 to Day 5 ]
  6. Taste Assessment, as Measured by Taste Questionnaire [ Time Frame: 2 days ]
  7. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline through end of study (up to 9 weeks) ]


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
Criteria

Inclusion Criteria

  • Non-smoker for at least six months
  • Healthy, as judged by the Investigator
  • Women of non-childbearing potential (WONCBP) who are not pregnant or lactating
  • Men must be willing to remain abstinent or agree to use contraceptive measures with partners who are women of childbearing potential (WOCBP), and must refrain from donating sperm, for at least 28 days after the last dose of study drug

Exclusion Criteria

  • History or evidence of any medical condition potentially altering the absorption, metabolism or elimination of drugs
  • History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or CNS infections (e.g. meningitis)
  • A history of clinically significant hypersensitivity (e.g., drugs, excipients) or allergic reactions
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities
  • Have used or intend to use over-the-counter or prescription medication including herbal medications within 30 days prior to dosing
  • Participation in an investigational drug or device study within 90 days prior to screening
  • Human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
  • Presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to starting study treatment

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): NCT03847987


Locations
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United States, Utah
PRA Health Sciences
Salt Lake City, Utah, United States, 84124
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: NCT03847987     History of Changes
Other Study ID Numbers: BP40950
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019

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