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Ipatasertib (GDC-0068) Study to Evaluate Formulation Change and Food Effect on Bioavailability in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02536391
Recruitment Status : Completed
First Posted : August 31, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This Phase I, open-label, randomized, 3-period crossover study was designed to determine the relative bioavailability of ipatasertib administered as capsule and tablet formulations to healthy volunteers. In addition, the influence of food on ipatasertib exposure will also be determined. Participants will be randomized to one of six treatment sequences to receive three treatments of a single oral administration of ipatasertib in, 1) tablet formulation in the fasted state, 2) capsule formulation in the fasted state or 3) tablet formulation in the fed state. Pharmacokinetics will be assessed, and standard physical and clinical evaluations will be performed throughout the study. Time on study is expected to be 3 weeks.

Condition or disease Intervention/treatment Phase
Cancer Drug: Ipatasertib (capsule) Drug: Ipatasertib (tablet) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Single-Dose, Randomized, Cross-Over, Relative Bioavailability, and Food Effect Study of Ipatasertib (GDC-0068) in Healthy Subjects
Study Start Date : October 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
Experimental: Sequence 1: Tablet/Capsule/Tablet with food
Day 1: ipatasertib tablet administered after fast, Day 8: ipatasertib capsule administered after fast, Day 15: ipatasertib tablet administered after high-fat meal.
Drug: Ipatasertib (capsule)
Orally administered single dose of Ipatasertib formulated as a capsule.
Other Name: GDC-0068 (capsule)

Drug: Ipatasertib (tablet)
Orally administered single dose of Ipatasertib formulated as a tablet.
Other Name: GDC-0068 (tablet)

Experimental: Sequence 2: Tablet/Tablet with food/Capsule
Day 1: ipatasertib tablet administered after fast, Day 8: ipatasertib tablet administered after high-fat meal, Day 15: ipatasertib capsule administered after fast.
Drug: Ipatasertib (capsule)
Orally administered single dose of Ipatasertib formulated as a capsule.
Other Name: GDC-0068 (capsule)

Drug: Ipatasertib (tablet)
Orally administered single dose of Ipatasertib formulated as a tablet.
Other Name: GDC-0068 (tablet)

Experimental: Sequence 3: Capsule/Tablet/Tablet with food
Day 1: ipatasertib capsule administered after fast, Day 8: ipatasertib tablet administered after fast, Day 15: ipatasertib tablet administered after high-fat meal.
Drug: Ipatasertib (capsule)
Orally administered single dose of Ipatasertib formulated as a capsule.
Other Name: GDC-0068 (capsule)

Drug: Ipatasertib (tablet)
Orally administered single dose of Ipatasertib formulated as a tablet.
Other Name: GDC-0068 (tablet)

Experimental: Sequence 4: Capsule/Tablet with food/Tablet
Day 1: ipatasertib capsule administered after fast, Day 8: ipatasertib tablet administered after high-fat meal, Day 15: ipatasertib tablet administered after fast.
Drug: Ipatasertib (capsule)
Orally administered single dose of Ipatasertib formulated as a capsule.
Other Name: GDC-0068 (capsule)

Drug: Ipatasertib (tablet)
Orally administered single dose of Ipatasertib formulated as a tablet.
Other Name: GDC-0068 (tablet)

Experimental: Sequence 5: Tablet with food/Tablet/Capsule
Day 1: ipatasertib tablet administered after high-fat meal, Day 8: ipatasertib tablet administered after fast, Day 15: ipatasertib capsule administered after fast.
Drug: Ipatasertib (capsule)
Orally administered single dose of Ipatasertib formulated as a capsule.
Other Name: GDC-0068 (capsule)

Drug: Ipatasertib (tablet)
Orally administered single dose of Ipatasertib formulated as a tablet.
Other Name: GDC-0068 (tablet)

Experimental: Sequence 6: Tablet with food/Capsule/Tablet
Day 1: ipatasertib tablet administered after high-fat meal, Day 8: ipatasertib capsule administered after fast, Day 15: ipatasertib tablet administered after fast.
Drug: Ipatasertib (capsule)
Orally administered single dose of Ipatasertib formulated as a capsule.
Other Name: GDC-0068 (capsule)

Drug: Ipatasertib (tablet)
Orally administered single dose of Ipatasertib formulated as a tablet.
Other Name: GDC-0068 (tablet)




Primary Outcome Measures :
  1. Maximum Observed Concentration (Cmax) of Ipatasertib [ Time Frame: Days 1, 8 and 15 ]
  2. Time to Maximum Concentration (tmax) of Ipatasertib [ Time Frame: Days 1, 8 and 15 ]
  3. Area Under the Concentration-time Curve (AUC) from Hour 0 to the Last Quantifiable Concentration (AUC0-t) of Ipatasertib [ Time Frame: Days 1, 8 and 15 ]
  4. Area Under the Concentration-time Curve (AUC) from Hour 0 Extrapolated to Infinity [ Time Frame: Days 1, 8 and 15 ]
  5. Apparent Terminal Elimination Half-Life (t1/2) of Ipatasertib [ Time Frame: Days 1, 8 and 15 ]
  6. Apparent Total Clearance (CL/F) of Ipatasertib [ Time Frame: Days 1, 8 and 15 ]
  7. Apparent Volume of Distribution (Vz/F) of Ipatasertib [ Time Frame: Days 1, 8 and 15 ]

Secondary Outcome Measures :
  1. Percentage of Participants with Adverse Events [ Time Frame: From check in (Day -1) to 30 days after the last dose of study drug ]


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:

  • Healthy males or females, between 18 and 55 years of age, inclusive
  • Body mass index between 18.5 and 29.9 kg/m^2, inclusive

Exclusion Criteria:

- Clinically significant findings from medical history or screening evaluations.


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): NCT02536391


Locations
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United States, Wisconsin
Madison, Wisconsin, United States, 53704
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: NCT02536391    
Other Study ID Numbers: GO29868
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016