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A Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Participants

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.
 
ClinicalTrials.gov Identifier: NCT02471859
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and Multiple-Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: GDC-3280 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and Multiple-Oral-Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects
Study Start Date : June 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Part A: GDC-3280
Participants in multiple cohorts and treatment periods will receive single doses of GDC-3280 under fed/fasting conditions.
Drug: GDC-3280
GDC-3280 at various doses, depending on the cohort and treatment period

Placebo Comparator: Part A: Placebo
Participants in multiple cohorts and treatment periods will receive single doses of placebo under fed/fasting conditions.
Drug: Placebo
Placebo at various doses, depending on the cohort and treatment period

Experimental: Part B: GCD-3280
Participants in different cohorts will receive GDC-3280 in multiple ascending doses under fed/fasting conditions.\n
Drug: GDC-3280
GDC-3280 at various doses, depending on the cohort and treatment period

Placebo Comparator: Part B: Placebo
Participants in different cohorts will receive placebo in multiple ascending doses under fed/fasting conditions.\n
Drug: Placebo
Placebo at various doses, depending on the cohort and treatment period




Primary Outcome Measures :
  1. Number of participants experiencing an adverse event [ Time Frame: Up to approximately 6 months ]

Secondary Outcome Measures :
  1. Maximum concentration (Cmax) for GDC-3280 [ Time Frame: Up to 4 days ]
  2. Time to Cmax (Tmax) for GDC-3280 [ Time Frame: Up to 4 days ]
  3. Total serum clearance for GDC-3280 [ Time Frame: Up to 4 days ]
  4. Volume of distribution for GDC-3280 [ Time Frame: Up to 4 days ]
  5. Elimination half-life for GDC-3280 [ Time Frame: Up to 4 days ]
  6. Serum GDC-3280 concentration-time data by dosing group [ Time Frame: Up to 4 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Is male or female, using highly effective contraception
  • Has a body mass index (BMI) 18.0 to 30.0 kg/m2, inclusive
  • Is in good general health
  • Having signed informed consent, is willing and able to comply with requirements of the study

Exclusion Criteria:

  • Does not satisfy all screening criteria per protocol
  • Is employed by or related to any personnel involved in the trial
  • Has any history or condition that per protocol or in the opinion of the investigator could compromise the participant's safety or analysis of results

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): NCT02471859


Locations
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United Kingdom
Leeds, United Kingdom, LS2 9LH
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02471859    
Other Study ID Numbers: GB29751
2015-000560-33 ( EudraCT Number )
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016