Healthy VolunteerPhase 1NCT02390492
A Phase I Bioavailability and Pharmacokinetic Study of [14C]-Ipatasertib Single Oral and Intravenous Doses in Healthy Male Subjects
A Phase 1 study testing Period 1 treatment and Period 2 treatment in people with Healthy Volunteer, run by Genentech, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Period 1 treatment and Period 2 treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Apr 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers 18 to 55 years of age, inclusive
- Body mass index (BMI) 18 to 32 kg/m2, inclusive
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-Ipatasertib (GDC-0068) Following a Single Oral Dose and to Investigate the Absolute Bioavailability Following Single Oral and Intravenous Doses in a Single Cohort of Healthy Male Subjects
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.
- Conditions
- Healthy Volunteer
- Being tested
- Period 1 treatment, Period 2 treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Period 1 treatmentDrug
200 mg oral ipatasertib followed 1 hour later by 80-mcg/800-nCi intravenous [14C]-ipatasertib on Day 1 of study
Period 2 treatmentDrug
200-mg/100-mcCi oral [14C]-ipatasertib on Day 15 of study
| Study group | Role | What they receive |
|---|---|---|
| Ipatasertib/[14C]-ipatasertib | Experimental | Not described Receives: Drug: Period 1 treatment; Drug: Period 2 treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): apparent terminal elimination half-life
Measured: Period 2: Approximately 2 weeks
Pharmacokinetics of ipatasertib (oral): apparent total clearance (CL/F)
Measured: Period 2: Approximately 2 weeks
Pharmacokinetics of ipatasertib (oral): apparent volume of distribution (Vz/F)
Measured: Period 2: Approximately 2 weeks
Elimination and pharmacokinetics: Total radioactivity concentration in whole blood, plasma, urine, and feces
Measured: Period 2: Approximately 2 weeks
Bioavailability: Absolute bioavailability of ipatasertib (area under the concentration-time curve)
Measured: Period 1: Approximately 4 days
Mass balance
Measured: Period 2: Approximately 2 weeks
Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): maximum observed concentration (Cmax)
Measured: Period 2: Approximately 2 weeks
Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): time to maximum observed concentration (Tmax)
Measured: 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)
Measured: Period 2: Approximately 2 weeks
Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): area under the concentration-time curve extrapolated to infinity (AUC0-inf)
Measured: Period 2: Approximately 2 weeks
Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): apparent terminal elimination rate constant
Measured: Period 2: Approximately 2 weeks
Secondary outcomes (10)
Pharmacokinetics of ipatasertib (oral and IV): terminal elimination rate constant adjusted for oral bioavailability as applicable
Measured: Period 1: Approximately 4 days
Pharmacokinetics of ipatasertib (oral and IV): terminal elimination half-life adjusted for oral bioavailability as applicable
Measured: Period 1: Approximately 4 days
Pharmacokinetics of ipatasertib (oral and IV): total clearance adjusted for oral bioavailability as applicable
Measured: Period 1: Approximately 4 days
Pharmacokinetics of ipatasertib (oral and IV): volume of distribution adjusted for oral bioavailability as applicable
Measured: Period 1: Approximately 4 days
Safety: Incidence of adverse events
Measured: Approximately 4 weeks
Elimination and pharmacokinetics: Metabolite concentration(s) in plasma, urine, and feces
Measured: Period 2: Approximately 2 weeks
Pharmacokinetics of ipatasertib (oral and IV): Cmax
Measured: Period 1: Approximately 4 days
Pharmacokinetics of ipatasertib (oral and IV): Tmax
Measured: Period 1: Approximately 4 days
Pharmacokinetics of ipatasertib (oral and IV): AUC0-t
Measured: Period 1: Approximately 4 days
Pharmacokinetics of ipatasertib (oral and IV): AUC0-inf
Measured: Period 1: Approximately 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390492
- Sponsor's protocol ID
- GP29067
- Status last verified
- Nov 2016
- First submitted
- 11 Mar 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-Ipatasertib (GDC-0068) Following a Single Oral Dose and to Investigate the Absolute Bioavailability Following Single Oral and Intravenous Doses in a Single Cohort of Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02390492
- Acronym / sponsor ID
- GP29067
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ipatasertib/[14C]-ipatasertib | Experimental | Drug: Period 1 treatment, Drug: Period 2 treatment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male volunteers 18 to 55 years of age, inclusive
- Body mass index (BMI) 18 to 32 kg/m2, inclusive
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Period 1 treatment200 mg oral ipatasertib followed 1 hour later by 80-mcg/800-nCi intravenous [14C]-ipatasertib on Day 1 of study | Drug | Ipatasertib/[14C]-ipatasertib |
| Period 2 treatment200-mg/100-mcCi oral [14C]-ipatasertib on Day 15 of study | Drug | Ipatasertib/[14C]-ipatasertib |
Primary outcome
Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): apparent terminal elimination half-life
Time frame: Period 2: Approximately 2 weeks
Pharmacokinetics of ipatasertib (oral): apparent total clearance (CL/F)
Time frame: Period 2: Approximately 2 weeks
Pharmacokinetics of ipatasertib (oral): apparent volume of distribution (Vz/F)
Time frame: Period 2: Approximately 2 weeks
Elimination and pharmacokinetics: Total radioactivity concentration in whole blood, plasma, urine, and feces
Time frame: Period 2: Approximately 2 weeks
Bioavailability: Absolute bioavailability of ipatasertib (area under the concentration-time curve)
Time frame: Period 1: Approximately 4 days
Mass balance
Time frame: Period 2: Approximately 2 weeks
Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): maximum observed concentration (Cmax)
Time frame: Period 2: Approximately 2 weeks
Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): time to maximum observed concentration (Tmax)
Time frame: 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)
Time frame: Period 2: Approximately 2 weeks
Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): area under the concentration-time curve extrapolated to infinity (AUC0-inf)
Time frame: Period 2: Approximately 2 weeks
Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): apparent terminal elimination rate constant
Time frame: Period 2: Approximately 2 weeks
10 secondary outcomes
Pharmacokinetics of ipatasertib (oral and IV): terminal elimination rate constant adjusted for oral bioavailability as applicable
Time frame: Period 1: Approximately 4 days
Pharmacokinetics of ipatasertib (oral and IV): terminal elimination half-life adjusted for oral bioavailability as applicable
Time frame: Period 1: Approximately 4 days
Pharmacokinetics of ipatasertib (oral and IV): total clearance adjusted for oral bioavailability as applicable
Time frame: Period 1: Approximately 4 days
Pharmacokinetics of ipatasertib (oral and IV): volume of distribution adjusted for oral bioavailability as applicable
Time frame: Period 1: Approximately 4 days
Safety: Incidence of adverse events
Time frame: Approximately 4 weeks
Elimination and pharmacokinetics: Metabolite concentration(s) in plasma, urine, and feces
Time frame: Period 2: Approximately 2 weeks
Pharmacokinetics of ipatasertib (oral and IV): Cmax
Time frame: Period 1: Approximately 4 days
Pharmacokinetics of ipatasertib (oral and IV): Tmax
Time frame: Period 1: Approximately 4 days
Pharmacokinetics of ipatasertib (oral and IV): AUC0-t
Time frame: Period 1: Approximately 4 days
Pharmacokinetics of ipatasertib (oral and IV): AUC0-inf
Time frame: Period 1: Approximately 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Period 1 treatment and Period 2 treatment in people with Healthy Volunteer, 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 4 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?
Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): apparent terminal elimination half-life (time frame: Period 2: Approximately 2 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.