NCT02390492

Brief Summary

This 2-period, open-label, nonrandomized study will be conducted to determine the absolute bioavailability as well as the absorption, metabolism, and excretion of ipatasertib and its metabolite(s). Healthy male participants will receive a single 200-mg oral dose of ipatasertib followed 1 hour later by an 80-mcg/800-nCi intravenous dose of \[14C\]-ipatasertib. After a 4-day observation period and 10-day washout, participants will receive a single 200-mg/100-mcCi oral dose of \[14C\]-ipatasertib with subsequent data collection for an additional 7 to 14 days until discharge criteria are met.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1 month

First QC Date

March 11, 2015

Last Update Submit

November 1, 2016

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (11)

  • Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): apparent terminal elimination half-life

    Period 2: Approximately 2 weeks

  • Pharmacokinetics of ipatasertib (oral): apparent total clearance (CL/F)

    Period 2: Approximately 2 weeks

  • Pharmacokinetics of ipatasertib (oral): apparent volume of distribution (Vz/F)

    Period 2: Approximately 2 weeks

  • Elimination and pharmacokinetics: Total radioactivity concentration in whole blood, plasma, urine, and feces

    Period 2: Approximately 2 weeks

  • Bioavailability: Absolute bioavailability of ipatasertib (area under the concentration-time curve)

    Period 1: Approximately 4 days

  • Mass balance

    Period 2: Approximately 2 weeks

  • Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): maximum observed concentration (Cmax)

    Period 2: Approximately 2 weeks

  • Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): time to maximum observed concentration (Tmax)

    Period 2: Approximately 2 weeks

  • Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): area under the concentration-time curve from Hour 0 to the last measurable concentration (AUC0-t)

    Period 2: Approximately 2 weeks

  • Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): area under the concentration-time curve extrapolated to infinity (AUC0-inf)

    Period 2: Approximately 2 weeks

  • Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): apparent terminal elimination rate constant

    Period 2: Approximately 2 weeks

Secondary Outcomes (10)

  • Pharmacokinetics of ipatasertib (oral and IV): terminal elimination rate constant adjusted for oral bioavailability as applicable

    Period 1: Approximately 4 days

  • Pharmacokinetics of ipatasertib (oral and IV): terminal elimination half-life adjusted for oral bioavailability as applicable

    Period 1: Approximately 4 days

  • Pharmacokinetics of ipatasertib (oral and IV): total clearance adjusted for oral bioavailability as applicable

    Period 1: Approximately 4 days

  • Pharmacokinetics of ipatasertib (oral and IV): volume of distribution adjusted for oral bioavailability as applicable

    Period 1: Approximately 4 days

  • Safety: Incidence of adverse events

    Approximately 4 weeks

  • +5 more secondary outcomes

Study Arms (1)

Ipatasertib/[14C]-ipatasertib

EXPERIMENTAL
Drug: Period 1 treatmentDrug: Period 2 treatment

Interventions

Period 1 treatmentDRUG

200 mg oral ipatasertib followed 1 hour later by 80-mcg/800-nCi intravenous \[14C\]-ipatasertib on Day 1 of study

Ipatasertib/[14C]-ipatasertib
Period 2 treatmentDRUG

200-mg/100-mcCi oral \[14C\]-ipatasertib on Day 15 of study

Ipatasertib/[14C]-ipatasertib

Eligibility Criteria

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

You may qualify if:

  • Healthy male volunteers 18 to 55 years of age, inclusive
  • Body mass index (BMI) 18 to 32 kg/m2, inclusive

You may not qualify if:

  • Females
  • Clinically significant findings from medical history or screening evaluations
  • Recent participation in any other investigational drug study or biologic agent study, or receipt of a previous radiolabeled investigational drug within 6 months prior to check-in
  • Significant radiation exposure within 12 months prior to check-in

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Madison, Wisconsin, 53704, United States

Location

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2015

First Posted

March 17, 2015

Study Start

March 1, 2015

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

US(1)