HealthyPhase 1NCT04720183
Drug-drug Interaction Study with GLPG3970 and Sulfasalazine in Adult, Healthy Subjects
A Phase 1 study testing Sulfasalazine and GLPG3970 in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in United States.
Trial summary
GLPG3970 will be given with sulfasalazine to investigate the effect of co-administration on the pharmacokinetics of sulfasalazine, and on the safety and tolerability of the drugs in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sulfasalazine and GLPG3970
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2021to 23 Apr 2021
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF). Females should be of non-childbearing potential.
- A body mass index (BMI) between 18.0 to 30.0 kg/m2, inclusive.
- A breast cancer resistance protein (BCRP) c421C/C genotype.
- Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to the first sulfasalazine administration. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be no greater than 1.5x upper limit of normal range (ULN). Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator.
- This list only contains the key inclusion criteria.
Who cannot join
- Known hypersensitivity to the investigational product (IP) (GLPG3970), or sulfasalazine, or sulfa drugs, or to their ingredients, or history of a significant allergic reaction to IP or sulfasalazine ingredients as determined by the investigator.
- Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or history of hepatitis from any cause with the exception of hepatitis A that was resolved at least 3 months prior to first dosing of sulfasalazine.
- History of or a current immunosuppressive condition (e.g. human immunodeficiency virus (HIV) infection).
- Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first dosing of sulfasalazine.
- Presence or sequelae of gastrointestinal, liver, kidney (estimated glomerular filtration rate (eGFR) <=90 mL/min/1.73 m2, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Subjects with an N-acetyltransferase 2 (NAT2) slow acetylator genotype.
- This list only contains the key exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Fixed Sequence, Open-label, Drug-drug Interaction Study to Evaluate the Effect of GLPG3970 on the Pharmacokinetics of Sulfasalazine in Adult, Healthy Subjects
GLPG3970 will be given with sulfasalazine to investigate the effect of co-administration on the pharmacokinetics of sulfasalazine, and on the safety and tolerability of the drugs in healthy adult subjects.
- Conditions
- Healthy
- Being tested
- Sulfasalazine, GLPG3970
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulfasalazineDrug
On Day 1, Day 5 and Day 9, a single oral dose of sulfasalazine tablets in fasted state.
GLPG3970Drug
On Day 5 and Day 9, a single dose of GLPG3970 oral solution in fasted state.
| Study group | Role | What they receive |
|---|---|---|
| Sulfasalazine + GLPG3970 | Experimental | Not described Receives: Drug: Sulfasalazine; Drug: GLPG3970 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax) of sulfasalazine
To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.
Measured: Between Day 1 pre-dose and Day 12
Cmax of sulfapyridine
To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.
Measured: Between Day 1 pre-dose and Day 12
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of sulfasalazine
To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.
Measured: Between Day 1 pre-dose and Day 12
AUC0-inf of sulfapyridine
To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.
Measured: Between Day 1 pre-dose and Day 12
Sulfapyridine to sulfasalazine AUC ratio
To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.
Measured: Between Day 1 pre-dose and Day 12
Secondary outcomes (3)
Number of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity
To evaluate the safety and tolerability of the coadministration of GLPG3970 with sulfasalazine in healthy subjects
Measured: From Day 1 through study completion, an average of 1 month
Maximum observed concentration (Cmax) of GLPG3970
To evaluate the PK of GLPG3970 in presence of sulfasalazine in healthy subjects
Measured: Between Day 5 pre-dose and Day 10
Area under the plasma concentration-time curve from time zero till the last observed quantifiable concentration (AUC0-t)
To evaluate the PK of GLPG3970 in presence of sulfasalazine in healthy subjects
Measured: Between Day 5 pre-dose and Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start11 Jan 2021
- Primary completion21 Apr 2021
- Study completion23 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalia Rueda-Rincon, MD, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720183
- Sponsor's protocol ID
- GLPG3970-CL-117
- Status last verified
- Jul 2021
- First submitted
- 19 Jan 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Fixed Sequence, Open-label, Drug-drug Interaction Study to Evaluate the Effect of GLPG3970 on the Pharmacokinetics of Sulfasalazine in Adult, Healthy Subjects
- ClinicalTrials.gov ID
- NCT04720183
- Acronym / sponsor ID
- GLPG3970-CL-117
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 21 Apr 2021 (actual)
- Study completion
- 23 Apr 2021 (actual)
- First posted
- 22 Jan 2021 (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.
GLPG3970 will be given with sulfasalazine to investigate the effect of co-administration on the pharmacokinetics of sulfasalazine, and on the safety and tolerability of the drugs in healthy adult subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sulfasalazine + GLPG3970 | Experimental | Drug: Sulfasalazine, Drug: GLPG3970 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF). Females should be of non-childbearing potential.
- A body mass index (BMI) between 18.0 to 30.0 kg/m2, inclusive.
- A breast cancer resistance protein (BCRP) c421C/C genotype.
- Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to the first sulfasalazine administration. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be no greater than 1.5x upper limit of normal range (ULN). Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator.
- This list only contains the key inclusion criteria.
Key exclusion criteria (7 listed)
- Known hypersensitivity to the investigational product (IP) (GLPG3970), or sulfasalazine, or sulfa drugs, or to their ingredients, or history of a significant allergic reaction to IP or sulfasalazine ingredients as determined by the investigator.
- Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or history of hepatitis from any cause with the exception of hepatitis A that was resolved at least 3 months prior to first dosing of sulfasalazine.
- History of or a current immunosuppressive condition (e.g. human immunodeficiency virus (HIV) infection).
- Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first dosing of sulfasalazine.
- Presence or sequelae of gastrointestinal, liver, kidney (estimated glomerular filtration rate (eGFR) <=90 mL/min/1.73 m2, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
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 |
|---|---|---|
| SulfasalazineOn Day 1, Day 5 and Day 9, a single oral dose of sulfasalazine tablets in fasted state. | Drug | Sulfasalazine + GLPG3970 |
| GLPG3970On Day 5 and Day 9, a single dose of GLPG3970 oral solution in fasted state. | Drug | Sulfasalazine + GLPG3970 |
Primary outcome
Maximum observed concentration (Cmax) of sulfasalazine
Time frame: Between Day 1 pre-dose and Day 12
To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.
Cmax of sulfapyridine
Time frame: Between Day 1 pre-dose and Day 12
To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of sulfasalazine
Time frame: Between Day 1 pre-dose and Day 12
To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.
AUC0-inf of sulfapyridine
Time frame: Between Day 1 pre-dose and Day 12
To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.
Sulfapyridine to sulfasalazine AUC ratio
Time frame: Between Day 1 pre-dose and Day 12
To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.
3 secondary outcomes
Number of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity
Time frame: From Day 1 through study completion, an average of 1 month
Maximum observed concentration (Cmax) of GLPG3970
Time frame: Between Day 5 pre-dose and Day 10
Area under the plasma concentration-time curve from time zero till the last observed quantifiable concentration (AUC0-t)
Time frame: Between Day 5 pre-dose and Day 10
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 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Natalia Rueda-Rincon, MD study director
Lakefront Biotherapeutics NV
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 Sulfasalazine and GLPG3970 in people with Healthy, run by Lakefront Biotherapeutics NV 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 5 inclusion and 7 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 19 Sep 2024. 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?
Maximum observed concentration (Cmax) of sulfasalazine (time frame: Between Day 1 pre-dose and Day 12). The study lists 5 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 19 Sep 2024.