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Trial record 1 of 1 for:    GN29829
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A Study to Determine the Safety, Tolerability, and Pharmacokinetics of GDC-0310 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT02742779
First received: March 11, 2016
Last updated: February 24, 2017
Last verified: February 2017
  Purpose
The purpose of this study is to evaluate the safety and tolerability of single and multiple orally ascending doses of GDC-0310 administered in healthy participants as 4 parts including Part 1- a single dose (SD) part using a powder-in-capsule (PIC) formulation, Part 2- a multiple dose (MD) part using a PIC formulation, Part 3- a SD part using a solution formulation, and Part 4- a MD part using a solution formulation. Effects of food on pharmacokinetics (PK) will also be explored.

Condition Intervention Phase
Healthy Volunteer Drug: GDC-0310 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Basic Science
Official Title: A Phase I, Randomized, Single and Multiple Ascending Dose, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, and Pharmacokinetics of GDC-0310 in Healthy Volunteers

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) [ Time Frame: Baseline up to Month 9 ]

Secondary Outcome Measures:
  • Maximum Plasma Concentration (Cmax) of GDC-0310 [ Time Frame: Pre dose up to Day 15 (detailed timeframe has been reported in the description) ]
    SD Cohort: Pre-dose (PD) (Hour[H] 0),5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H post-dose(PoD); MD Cohort:PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14;Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15

  • Minimum Plasma Concentration (Cmin) of GDC-0310 [ Time Frame: Pre dose up to Day 15 (detailed timeframe has been reported in the description) ]
    SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15

  • Time to Maximum Plasma Concentration (tmax) of GDC-0310 [ Time Frame: Pre dose up to Day 15 (detailed timeframe has been reported in the description) ]
    SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15

  • Area Under the Concentration-Time Curve (AUC) of GDC-0310 [ Time Frame: Pre dose up to Day 15 (detailed timeframe has been reported in the description) ]
    SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15

  • Apparent Clearance (CL/F) of GDC-0310 [ Time Frame: Pre dose up to Day 15 (detailed timeframe has been reported in the description) ]
    SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15

  • Apparent Terminal Volume of Distribution (Vz/F) of GDC-0310 [ Time Frame: Pre dose up to Day 15 (detailed timeframe has been reported in the description) ]
    SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15

  • Apparent Terminal Elimination Rate Constant (ke) of GDC-0310 [ Time Frame: Pre dose up to Day 15 (detailed timeframe has been reported in the description) ]
    SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15

  • Apparent Terminal Half-Life (t1/2) of GDC-0310 [ Time Frame: Pre dose up to Day 15 (detailed timeframe has been reported in the description) ]
    SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15

  • Pharmacokinetics (PK) Dose Proportionality as Assessed With Cmax of GDC-0310 [ Time Frame: Pre dose up to Day 15 (detailed timeframe has been reported in the description) ]
    SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15

  • PK Dose Proportionality as Assessed With AUC of GDC-0310 [ Time Frame: Pre dose up to Day 15 (detailed timeframe has been reported in the description) ]
    SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15

  • Accumulation Ratio for MD Cohort [ Time Frame: Pre dose up to Day 15 (detailed timeframe has been reported in the description) ]
    PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15


Enrollment: 95
Study Start Date: September 2015
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High-Fat Meal SD Cohort: PIC (Part 1)
Participants will receive GDC-0310 single ascending dose based on PK results from earlier SD cohorts up to an established dose yielding at least a 2-fold exposure margin to the MTD administered orally following a high-fat meal after a 8-hour/overnight fast using PIC on Day 1 of the treatment period (5 days) in an additional cohort of Part 1.
Drug: GDC-0310
Participants will receive single or multiple ascending doses of GDC-0310 orally in fasted or fed state.
Experimental: High-Fat Meal SD Cohort: Solution Formulation (Part 3)
Participants will receive GDC-0310 single ascending dose based on PK results from earlier SD cohorts up to an established dose yielding at least a 2-fold exposure margin to the MTD administered orally following a high-fat meal after a 8-hour/overnight fast using solution on Day 1 of the treatment period (5 days) in an additional cohort of Part 3.
Drug: GDC-0310
Participants will receive single or multiple ascending doses of GDC-0310 orally in fasted or fed state.
Experimental: Low-Fat Meal SD Cohort: PIC (Part 1)
Participants will receive GDC-0310 single ascending dose given orally using PIC based on PK results from earlier SD cohorts up to an established dose yielding at least a 2-fold exposure margin to the MTD administered orally following a low-fat meal after an 8-hour/overnight fast using PIC on Day 1 of the treatment period (5 days) in an additional cohort of Part 1.
Drug: GDC-0310
Participants will receive single or multiple ascending doses of GDC-0310 orally in fasted or fed state.
Experimental: Low-Fat Meal SD Cohort: Solution Formulation (Part 3)
Participants will receive GDC-0310 single ascending dose given orally using PIC based on PK results from earlier SD cohorts up to an established dose yielding at least a 2-fold exposure margin to the MTD administered orally following a low-fat meal after an 8-hour/overnight fast using solution on Day 1 of the treatment period (5 days) in an additional cohort of Part 1.
Drug: GDC-0310
Participants will receive single or multiple ascending doses of GDC-0310 orally in fasted or fed state.
Experimental: MD Cohort: PIC (Part 2)
Participants will receive multiple ascending dose administered orally using PIC from Day 1 to Day 13 twice daily (BID) or may even be thrice daily (TID) or four times a day (QD) depending on clinical PK, followed by morning dose on Day 14 in 7 cohorts of Part 2.
Drug: GDC-0310
Participants will receive single or multiple ascending doses of GDC-0310 orally in fasted or fed state.
Experimental: MD Cohort: Solution Formulation (Part 4)
Participants will receive multiple ascending dose in fed or fast condition, administered orally using solution from Day 1 to Day 13 BID or may even be TID or QD depending on clinical PK, followed by morning dose on Day 14 in 7 cohorts of Part 2.
Drug: GDC-0310
Participants will receive single or multiple ascending doses of GDC-0310 orally in fasted or fed state.
Placebo Comparator: Placebo PIC
Participants will receive placebo matched to GDC-0310 single or multiple ascending dose administered orally in the fasted (SD cohorts) or fed state using PIC on Day 1 of the treatment period (5 days) to the SD cohorts and from Day 1 to 14 BID or may even be TID or QD depending on clinical PK, to the MD cohorts.
Drug: Placebo
Participants will receive placebo matched to GDC-0310 as single or multiple oral dose in fasted or fed state.
Placebo Comparator: Placebo Solution
Participants will receive placebo matched to GDC-0310 single or multiple ascending dose administered orally in the fasted (SD cohorts) or fed state using PIC on Day 1 of the treatment period (5 days) to the SD cohorts and from Day 1 to 14 BID or may even be TID or QD depending on clinical PK, to the MD cohorts.
Drug: Placebo
Participants will receive placebo matched to GDC-0310 as single or multiple oral dose in fasted or fed state.
Experimental: SD Cohort: PIC (Part 1)
Participants will receive GDC-0310 single ascending dose administered orally in the fasted state using PIC on Day 1 of the treatment period (5 days) in the 9 cohorts of Part 1.
Drug: GDC-0310
Participants will receive single or multiple ascending doses of GDC-0310 orally in fasted or fed state.
Experimental: SD Cohort: Solution Formulation (Part 3)
Participants will receive GDC-0310 single ascending dose administered orally in the fasted state using solution formulation on Day 1 of the treatment period (5 days) in the 9 cohorts of Part 3.
Drug: GDC-0310
Participants will receive single or multiple ascending doses of GDC-0310 orally in fasted or fed state.

  Eligibility

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

Inclusion Criteria:

  • Female participants of non-childbearing potential must meet the criteria defined in the protocol
  • Body mass index within the range of 18.0 to 30.0 kilograms per meter square (kg/m^2), inclusive, and a minimum weight of 50.0 kg

Exclusion Criteria:

  • Have a clinically significant medical condition (e.g., hypertension; diabetes; impaired cardiac, renal or hepatic function; hyperthyroidism or hypothyroidism; neurological disorder; pain condition; hematologic disorder; psychiatric disorders requiring chronic medication) including any medical condition requiring treatment with medication (other than study drugs and medications specifically allowed by this protocol) during participation in the study
  • Evidence of any hepatic impairment including any abnormal levels (i.e., greater than [>] 1 × the upper limit of normal) of alkaline phosphatase, gamma glutamyl transpeptidase, alanine transaminase, aspartate aminotransferase or bilirubin
  • Evidence of clinically significant renal impairment defined as >1.3 × upper limit of normal creatinine
  • History or presence of alcoholism or alcohol or substance abuse (not including nicotine or caffeine) within the previous 2 years or routinely consume 2 or more alcohol-containing beverages per day or more than 10 units of alcohol per week (1 unit =150 milliliter (mL) of wine, 360 mL of beer, or 45 mL of 40 percent (%) alcohol)
  • Have a positive urine drug test at screening or check-in or any other point during the study
  • Are habituated to analgesic drugs (i.e., routine use of oral analgesics 5 or more times per week) or have a history of chronic pain requiring opiate use
  • Have used tobacco or nicotine-containing products within 3 months before study drug administration
  • Have clinically significant abnormal laboratory values as determined by the principal investigator
  • Have used any prescription or over-the-counter medication or supplement within 14 days or 5 times the elimination half-life (whichever is longer) before administration of study drug and until the end of their participation in the study
  • History of seizures, including in first degree relatives
  • History of heritable myopathy, weakness, or paralysis, including in first degree relatives indicative of familial periodic paralysis
  • Current treatment with medications that are well known to prolong the QT interval
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02742779

Locations
United States, Utah
PRA Health Sciences
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02742779     History of Changes
Other Study ID Numbers: GN29829
Study First Received: March 11, 2016
Last Updated: February 24, 2017

Additional relevant MeSH terms:
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on June 26, 2017