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CancerPhase 1NCT02536391

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

A Phase 1 study testing Ipatasertib (capsule) and Ipatasertib (tablet) in people with Cancer, run by Genentech, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Cancer
What is being tested?
Ipatasertib (capsule) and Ipatasertib (tablet)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
Oct 2015to Nov 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Clinically significant findings from medical history or screening evaluations.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Study site

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: A Phase 1, Single-Dose, Randomized, Cross-Over, Relative Bioavailability, and Food Effect Study of Ipatasertib (GDC-0068) in Healthy Subjects

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.

Conditions
Cancer
Being tested
Ipatasertib (capsule), Ipatasertib (tablet)
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ipatasertib (capsule)Drug

    Also called GDC-0068 (capsule)

    Orally administered single dose of Ipatasertib formulated as a capsule.

  • Ipatasertib (tablet)Drug

    Also called GDC-0068 (tablet)

    Orally administered single dose of Ipatasertib formulated as a tablet.

Study groups in NCT02536391
Study groupRoleWhat they receive
Sequence 1: Tablet/Capsule/Tablet with foodExperimentalDay 1: ipatasertib tablet administered after fast, Day 8: ipatasertib capsule administered after fast, Day 15: ipatasertib tablet administered after high-fat meal.
Receives: Drug: Ipatasertib (capsule); Drug: Ipatasertib (tablet)
Sequence 2: Tablet/Tablet with food/CapsuleExperimentalDay 1: ipatasertib tablet administered after fast, Day 8: ipatasertib tablet administered after high-fat meal, Day 15: ipatasertib capsule administered after fast.
Receives: Drug: Ipatasertib (capsule); Drug: Ipatasertib (tablet)
Sequence 3: Capsule/Tablet/Tablet with foodExperimentalDay 1: ipatasertib capsule administered after fast, Day 8: ipatasertib tablet administered after fast, Day 15: ipatasertib tablet administered after high-fat meal.
Receives: Drug: Ipatasertib (capsule); Drug: Ipatasertib (tablet)
Sequence 4: Capsule/Tablet with food/TabletExperimentalDay 1: ipatasertib capsule administered after fast, Day 8: ipatasertib tablet administered after high-fat meal, Day 15: ipatasertib tablet administered after fast.
Receives: Drug: Ipatasertib (capsule); Drug: Ipatasertib (tablet)
Sequence 5: Tablet with food/Tablet/CapsuleExperimentalDay 1: ipatasertib tablet administered after high-fat meal, Day 8: ipatasertib tablet administered after fast, Day 15: ipatasertib capsule administered after fast.
Receives: Drug: Ipatasertib (capsule); Drug: Ipatasertib (tablet)
Sequence 6: Tablet with food/Capsule/TabletExperimentalDay 1: ipatasertib tablet administered after high-fat meal, Day 8: ipatasertib capsule administered after fast, Day 15: ipatasertib tablet administered after fast.
Receives: Drug: Ipatasertib (capsule); Drug: Ipatasertib (tablet)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Concentration (Cmax) of Ipatasertib

    Measured: Days 1, 8 and 15

  2. Time to Maximum Concentration (tmax) of Ipatasertib

    Measured: 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

    Measured: Days 1, 8 and 15

  4. Area Under the Concentration-time Curve (AUC) from Hour 0 Extrapolated to Infinity

    Measured: Days 1, 8 and 15

  5. Apparent Terminal Elimination Half-Life (t1/2) of Ipatasertib

    Measured: Days 1, 8 and 15

  6. Apparent Total Clearance (CL/F) of Ipatasertib

    Measured: Days 1, 8 and 15

  7. Apparent Volume of Distribution (Vz/F) of Ipatasertib

    Measured: Days 1, 8 and 15

Secondary outcomes (1)

  1. Percentage of Participants with Adverse Events

    Measured: From check in (Day -1) to 30 days after the last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02536391
Sponsor's protocol ID
GO29868
Status last verified
Nov 2016
First submitted
27 Aug 2015
Last updated
2 Nov 2016
Results posted
No

Publications

  • Malhi V, Budha N, Sane R, Huang J, Liederer B, Meng R, Patel P, Deng Y, Cervantes A, Tabernero J, Musib L. Single- and multiple-dose pharmacokinetics, potential for CYP3A inhibition, and food effect in patients with cancer and healthy subjects receiving ipatasertib. Cancer Chemother Pharmacol. 2021 Dec;88(6):921-930. doi: 10.1007/s00280-021-04344-9. Epub 2021 Sep 1.

    PubMed 34471960

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ipatasertib (capsule) and Ipatasertib (tablet) in people with Cancer, run by Genentech, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Concentration (Cmax) of Ipatasertib (time frame: Days 1, 8 and 15). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02536391, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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