Anemia, Sickle CellPhase 1NCT02497924
A Study of the Absorption, Metabolism, and Excretion of GBT440 in Healthy Male Subjects
A Phase 1 study testing GBT440 in people with Anemia, Sickle Cell, run by Global Blood Therapeutics at 1 site in United States.
Trial summary
This study will provide information regarding the metabolic pathway of GBT440, the need for evaluation of potential drug-drug interactions, and the need for studies in special populations. 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
- Anemia, Sickle Cell
- What is being tested?
- GBT440
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jul 2016
- 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; non-smoking male; 18 to 55 years old, inclusive
- Weighs at least 50 kg and not more than 110 kg
- Agrees to use contraception
- Willing and able to give written informed consent
Who cannot join
- Evidence or history of clinically significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
- History of stomach or intestinal surgery that would potentially alter drug absorption
- History of hypersensitivity or allergy to drugs, foods, or other substances
- History or presence of abnormal electrocardiogram
- Exposure to significant radiation or participated in more than 1 other radiolabeled study drug trial within 12 months of Screening
- Participated in another clinical trial of an investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to Screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Early Clinical Services
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1 Study to Investigate Absorption, Metabolism, and Excretion After Establishment of Steady State Via GBT440 Loading and Maintenance Dosing Followed by a Single Oral Dose Administration of [14C]-GBT440 in Healthy Male Subjects
This study will provide information regarding the metabolic pathway of GBT440, the need for evaluation of potential drug-drug interactions, and the need for studies in special populations. The administration of radiolabeled drug is necessary to fully characterize the rates and routes of elimination of GBT440, providing further quantitative information on the disposition of GBT440. The results from this study will permit a comprehensive comparison between animal and human routes of elimination and metabolic profiles of GBT440.
- Conditions
- Anemia, Sickle Cell
- Being tested
- GBT440
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBT440Drug
GBT440 capsules followed by single dose of [C14] GBT440 oral suspension
| Study group | Role | What they receive |
|---|---|---|
| GBT440 | Experimental | GBT440 / [C14] GBT440 Receives: Drug: GBT440 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the whole blood and plasma concentration versus time curve (AUC)
Measured: 0 to 648 hours post dose
Peak whole blood and plasma concentration (Cmax)
Measured: 0 to 168 hours post dose
Time to peak whole blood and plasma concentration (Tmax)
Measured: 0 to 168 hours post dose
Half-life (T 1/2)
Measured: 0 to 168 hours post dose
Percent total recovery of radioactivity in blood, urine, and feces
Measured: 0 to 648 hours post dose
Identification of metabolites in whole blood, plasma, urine, and feces following [C14] GBT440 administration
Measured: 0 to 168 hours post dose
Secondary outcomes (1)
Number of participants with adverse events
Measured: Baseline to 27 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Sickle CellStudies of the same condition, open and under way.
- 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global Blood Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carla Washington, PhD, Study director, Global Blood Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497924
- Sponsor's protocol ID
- GBT440-002
- Status last verified
- Sep 2015
- First submitted
- 13 Jul 2015
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Investigate Absorption, Metabolism, and Excretion After Establishment of Steady State Via GBT440 Loading and Maintenance Dosing Followed by a Single Oral Dose Administration of [14C]-GBT440 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02497924
- Acronym / sponsor ID
- GBT440-002
- Conditions
- Anemia, Sickle Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Global Blood TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 15 Jul 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 study will provide information regarding the metabolic pathway of GBT440, the need for evaluation of potential drug-drug interactions, and the need for studies in special populations. The administration of radiolabeled drug is necessary to fully characterize the rates and routes of elimination of GBT440, providing further quantitative information on the disposition of GBT440. The results from this study will permit a comprehensive comparison between animal and human routes of elimination and metabolic profiles of GBT440.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GBT440 | Experimental | Drug: GBT440GBT440 / [C14] GBT440 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy; non-smoking male; 18 to 55 years old, inclusive
- Weighs at least 50 kg and not more than 110 kg
- Agrees to use contraception
- Willing and able to give written informed consent
Key exclusion criteria (6 listed)
- Evidence or history of clinically significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
- History of stomach or intestinal surgery that would potentially alter drug absorption
- History of hypersensitivity or allergy to drugs, foods, or other substances
- History or presence of abnormal electrocardiogram
- Exposure to significant radiation or participated in more than 1 other radiolabeled study drug trial within 12 months of Screening
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 |
|---|---|---|
| GBT440GBT440 capsules followed by single dose of [C14] GBT440 oral suspension | Drug | GBT440 |
Primary outcome
Area under the whole blood and plasma concentration versus time curve (AUC)
Time frame: 0 to 648 hours post dose
Peak whole blood and plasma concentration (Cmax)
Time frame: 0 to 168 hours post dose
Time to peak whole blood and plasma concentration (Tmax)
Time frame: 0 to 168 hours post dose
Half-life (T 1/2)
Time frame: 0 to 168 hours post dose
Percent total recovery of radioactivity in blood, urine, and feces
Time frame: 0 to 648 hours post dose
Identification of metabolites in whole blood, plasma, urine, and feces following [C14] GBT440 administration
Time frame: 0 to 168 hours post dose
1 secondary outcome
Number of participants with adverse events
Time frame: Baseline to 27 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 12 Apr 2017.
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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.
Carla Washington, PhD study director
Global Blood Therapeutics
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 GBT440 in people with Anemia, Sickle Cell, run by Global Blood Therapeutics 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 4 inclusion and 6 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 12 Apr 2017. 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?
Area under the whole blood and plasma concentration versus time curve (AUC) (time frame: 0 to 648 hours post dose). The study lists 6 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 12 Apr 2017.