Phase 1Phase 1NCT03740217

Comparison of the Relative Oral Bioavailability of GKT137831 Formulated in Capsules or in Tablets

A Phase 1 study testing GKT137831 in people with Phase 1, run by Calliditas Therapeutics AB at 1 site in France.

Completed

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

Trial summary

The study will be a comparative oral bioavailability study between GKT137831 capsules and tablets, together with an assessment of the impact of concomitant food intake on the relative bioavailability of GKT137831 tablets. This will be a randomized three-way open cross-over study. Read more about this study

Who is it for?: Ages 18 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for: Phase 1
What is being tested?: GKT137831
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteFrance
Study dates: 19 Dec 2018to 6 Feb 2019
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 60 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subject, aged 18 to 60 years inclusive;
Non-smoker subject or smoker of not more than 5 cigarettes a day ;
No history of alcohol or drug abuse
Body Mass Index (BMI) between 18 and 27 5 kg/m2 inclusive;
Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination);
Signing a written informed consent prior to selection;

Who cannot join

Blood donation (including in the frame of a clinical study) within 2 months before administration;
General anaesthesia within 3 months before administration;
Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician;
Inability to abstain from intensive muscular effort;
No possibility of contact in case of emergency;
Any drug intake (except paracetamol) during the last month prior to the first administration;

Show all 13Show fewer

History or presence of drug or alcohol abuse (alcohol consumption > 40 grams / day);
Excessive consumption of beverages with xanthine bases (> 4 cups or glasses / day);
Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests;
Positive results of screening for drugs of abuse;
Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
Exclusion period of a previous study;
Administrative or legal supervision;

Trial locations and contacts

1 site in 1 country.

France1 site

Eurofins Optimed
Gières, 38610

Other trials in France

About this study

Official title: Comparison of the Relative Oral Bioavailability of GKT137831 Formulated in Capsules or in Tablets and Evaluation of the Potential Impact of Concomitant Food Intake on the Relative Bioavailability of GKT137831 in Healthy Male Subjects

This will be a randomized three-way open cross-over study.

Conditions: Phase 1
Being tested: GKT137831

What participants receive

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

GKT137831Drug
Also called NOX1/4 inhibitor
oral bioavailable small molecule that selectively inhibit NOX1 and NOX4

Study groups in NCT03740217
Study group	Role	What they receive
Treatment A	Other	Single oral dose of 400 mg GKT137831 administered as 4 x 100 mg capsules in fasting conditions. Receives: Drug: GKT137831
Treatment B:	Other	Single oral dose of 400 mg GKT137831 administered as 1 x 400 mg tablets in fasting conditions. Receives: Drug: GKT137831
Treatment C	Other	Single oral dose of 400 mg GKT137831 administered as 1 x 400 mg tablets in fed conditions. Receives: Drug: GKT137831

What is being measured

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

Oral bioavailability (Fz)
To compare the relative oral bioavailability GKT137831 formulated in capsules or in tablets in healthy male subjects.
Measured: 72 hours
Food effect on Oral bioavailability (Fz)
To assess the impact of concomitant food intake on the relative bioavailability of GKT137831 after single oral dose administration of a 400 mg GKT137831 tablet in healthy male subjects.
Measured: 72 hours

Secondary outcomes (3)

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
To compare the safety and tolerability of single oral dose administration of 400 mg GKT137831 formulated in capsules or in tablets, and to evaluate the potential impact of concomitant food intake on the safety and tolerability of single oral dose administration of 400 mg GKT137831 tablet in healthy adult male subjects.
Measured: 7 days
Oral bioavailability of GKT138184
To compare the relative oral bioavailability GKT138184 after oral administration of GKT137831 formulated in capsules or in tablets in healthy male subjects.
Measured: 72 hours
Food effect on oral bioavailability of GKT138184
To assess the impact of concomitant food intake on the relative bioavailability of GKT138184 after single oral dose administration of a 400 mg GKT137831 tablet in healthy male subjects.
Measured: 72 hours

Timeline

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

19 Dec 20186 Feb 2019

First posted14 Nov 2018
Study start19 Dec 2018
Primary completion6 Feb 2019
Study completion6 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Phase 1Studies 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: Randomised
Intervention model: Crossover
Model description: Subject will be randomly allocated with different formulations of treatment or conditions (Fasting or Fed) during three periods (P1, P2 and P3).
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03740217
Sponsor's protocol ID: GSN000299
Status last verified: Jan 2019
First submitted: 12 Oct 2018
Last updated: 30 Jun 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Phase 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Relative Oral Bioavailability of GKT137831 Formulated in Capsules or in Tablets and Evaluation of the Potential Impact of Concomitant Food Intake on the Relative Bioavailability of GKT137831 in Healthy Male Subjects
ClinicalTrials.gov ID: NCT03740217
Acronym / sponsor ID: GSN000299
Conditions: Phase 1
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Calliditas Therapeutics ABIndustry (pharma, biotech, devices)
Collaborators: Eurofins Optimed, York Bioanalytical Solution
Study start: 19 Dec 2018 (actual)
Primary completion: 6 Feb 2019 (actual)
Study completion: 6 Feb 2019 (actual)
First posted: 14 Nov 2018 (actual)
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 will be a randomized three-way open cross-over study.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3
Model description: Subject will be randomly allocated with different formulations of treatment or conditions (Fasting or Fed) during three periods (P1, P2 and P3).

Arm	Type	Receives
Treatment A	Other	Drug: GKT137831Single oral dose of 400 mg GKT137831 administered as 4 x 100 mg capsules in fasting conditions.
Treatment B:	Other	Drug: GKT137831Single oral dose of 400 mg GKT137831 administered as 1 x 400 mg tablets in fasting conditions.
Treatment C	Other	Drug: GKT137831Single oral dose of 400 mg GKT137831 administered as 1 x 400 mg tablets in fed conditions.

Who may qualify

Ages: 18 to 60 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Healthy male subject, aged 18 to 60 years inclusive;
Non-smoker subject or smoker of not more than 5 cigarettes a day ;
No history of alcohol or drug abuse
Body Mass Index (BMI) between 18 and 27 5 kg/m2 inclusive;
Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination);

Key exclusion criteria (13 listed)

Blood donation (including in the frame of a clinical study) within 2 months before administration;
General anaesthesia within 3 months before administration;
Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician;
Inability to abstain from intensive muscular effort;
No possibility of contact in case of emergency;

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
GKT137831Also: NOX1/4 inhibitororal bioavailable small molecule that selectively inhibit NOX1 and NOX4	Drug	Treatment A, Treatment B:, Treatment C

Primary outcome

Oral bioavailability (Fz)
Time frame: 72 hours
To compare the relative oral bioavailability GKT137831 formulated in capsules or in tablets in healthy male subjects.
Food effect on Oral bioavailability (Fz)
Time frame: 72 hours
To assess the impact of concomitant food intake on the relative bioavailability of GKT137831 after single oral dose administration of a 400 mg GKT137831 tablet in healthy male subjects.

3 secondary outcomes

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 7 days
Oral bioavailability of GKT138184
Time frame: 72 hours
Food effect on oral bioavailability of GKT138184
Time frame: 72 hours

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 30 Jun 2022.
Individual participant dataSharing planned: Undecided

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Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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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.

Yves DONAZZOLO, MD principal investigator

Eurofins Optimed

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 GKT137831 in people with Phase 1, run by Calliditas Therapeutics AB at 1 site in France.

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 6 inclusion and 13 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 30 Jun 2022. 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 France. 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?

Oral bioavailability (Fz) (time frame: 72 hours). The study lists 2 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 NCT03740217.

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 30 Jun 2022.