NCT02063581

Brief Summary

This Phase I, open-label, randomized, 2-period crossover study was designed to determine the relative bioavailability of ipatasertib administered as capsule and tablet formulations to healthy adult volunteers. Participants will be randomized to one of two treatment sequences to receive a single oral administration of ipatasertib in tablet or capsule formulation followed, after a washout period, by a single oral administration of ipatasertib in the second formulation. Pharmacokinetics will be assessed, and standard physical and clinical evaluations will be performed throughout the study. Time on study is expected to be 2 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

28 days

First QC Date

February 12, 2014

Last Update Submit

November 1, 2016

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (3)

  • Area under the concentration time curve (AUC) of ipatasertib

    Days 1-13

  • Maximum concentration (Cmax) reached of ipatasertib

    Days 1-13

  • Time to maximum concentration (Tmax) of ipatasertib

    Days 1-13

Secondary Outcomes (1)

  • Incidence of adverse events

    From check-in (Day -1) to Day 13

Study Arms (2)

Sequence 1: Tablet followed by Capsule

EXPERIMENTAL
Drug: ipatasertib (Capsule)Drug: ipatasertib (Tablet)

Sequence 2: Capsule followed by Tablet

EXPERIMENTAL
Drug: ipatasertib (Capsule)Drug: ipatasertib (Tablet)

Interventions

ipatasertib (Capsule)DRUG

Orally administered single dose of Ipatasertib formulated as a capsule.

Sequence 1: Tablet followed by CapsuleSequence 2: Capsule followed by Tablet
ipatasertib (Tablet)DRUG

Orally administered single dose of Ipatasertib formulated as a tablet.

Sequence 1: Tablet followed by CapsuleSequence 2: Capsule followed by Tablet

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female volunteers aged 18 to 55 years, inclusive
  • Body mass index (BMI) from 18.5-29.9 kg/m2, inclusive

You may not qualify if:

  • Clinically significant findings from medical history or screening evaluations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

ipatasertibCapsulesTablets

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 14, 2014

Study Start

February 1, 2014

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

US(1)