HealthyPhase 1NCT03800472

A Study Investigating the Safety, Absorption and Elimination of GLPG3312, a New Drug in the Treatment of Inflammatory Diseases

A Phase 1 study testing GLPG3312 IR, GLPG3312 MR and GLPG3312 FE MR in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Netherlands.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: GLPG3312 IR, GLPG3312 MR and GLPG3312 FE MR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 95 participants
Where: 1 siteNetherlands
Study dates: 15 Jan 2019to 10 Mar 2020
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 to 55 years of age (extremes included), on the date of signing the Informed Consent Form (ICF). Female should be of non-childbearing potential defined as permanently surgically sterile (bilateral oophorectomy, i.e. surgical removal of ovaries, bilateral salpingectomy or hysterectomy, i.e. surgical removal of uterus), or with no menses for 12 or more months without an alternative medical cause AND a folliclestimulating hormone (FSH) level >35 IU/L. These subjects must also have a negative pregnancy test. For surgical sterilization, documented confirmation will be requested.
A body mass index (BMI) between 18 to 30 kg/m2, inclusive.
Subject must be able and willing to comply with restrictions on prior medication.
Male subjects with female partners of childbearing potential must be willing to comply with contraceptive methods.
Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and fasting clinical laboratory safety tests. Clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered nonclinically significant in the opinion of the investigator. At minimum hemoglobin, alanine aminotransferase (ALT), creatinine, creatine kinase-myoglobin (CK-MB), High Sensitivity Troponin I, Troponin T and alkaline phosphatase must be within the normal range, aspartate aminotransferase (AST) must be no greater than 1.5x upper limit of normal range (ULN).

Who cannot join

Known hypersensitivity to IMP ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator.
Positive serology for 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 the IMP.
History of, or a current immunosuppressive condition (e.g. HIV infection).
Having any illness (e.g. active allergy, fever, hypersensitivity reactions) judged by the investigator as clinically significant, in the 3 months prior to first dosing of the IMP.
Any history, or current sign or symptom of a cardiovascular, renal, or metabolic bone disease or disease of bone remodelling (with the exception of uncomplicated accidental bone fractures that recovered uncompromised at least 1 year ago), or any history of endocrine disease, including an abnormal laboratory result for prespecified clinical laboratory safety parameters related to these conditions.
Presence or sequelae of gastrointestinal, liver, kidney (creatinine clearance ≤80 mL/min/1.73m2, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula: if calculated result is ≤80 mL/min/1.73m2, a 24-hours urine collection can be done), or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.

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History of malignancy within the past 5 years prior to screening with the exception of excised and curatively treated non-metastatic cell carcinoma of the skin or carcinoma in situ of the cervix which is considered cured with minimal risk of recurrence.
Significant blood loss (including blood donation >450 mL), or transfusion of any blood product within 12 weeks prior to screening.
Treatment with any medication (including over-the-counter and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements) except occasional paracetamol (maximum dose of 2 g/day and a maximum of 10 g/ 2 weeks) in the last 2 weeks or 5 half-lives of the drug, whichever is longer, prior to the first dosing of the IMP.
Active drug abuse or alcohol abuse (alcohol abuse defined as regular weekly intake of more than 14 units) within 2 years prior to first IMP administration.
Active smoker and/or has used nicotine or nicotine-containing products within the past 6 months before the first IMP administration.
Regular consumption of a large quantity of caffeinated coffee, tea (> 6 cups per day) or equivalent.
Concurrent participation or participation in a drug, drug/device or biologic investigational research study within 12 weeks or 5 half-lives of the IMP, whichever is longer, prior to first dosing of the investigational medicinal product (IMP).
Any clinical laboratory test result outside of the reference ranges considered by the investigator as clinically significant. Hemoglobin, ALT, creatinine, CK-MB, High Sensitivity Troponin I, Troponin T, or alkaline phosphatase outside normal range, AST result greater than 1.5x ULN.
History or presence of clinically significant abnormalities detected on 12-lead ECG of either rhythm or conduction (e.g. known long QT syndrome). A first-degree atrioventricular block will not be considered as a significant abnormality. QTcF = QT x (1000/RR)1/3 (QTcF) >450 ms (male), >460 ms (female) (mean values per parameter will be considered) detected on the 12-lead ECG.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

PRA Health Sciences
Groningen, 9728 NZ

Other trials in Netherlands

About this study

Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Single-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Including the Effect of Food, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG3312, in Adult, Healthy Subjects

The purpose of this study is to investigate how safe 2 different formulations (immediate-release (IR) and modified-release (MR) tablets) of the new compound GLPG3312 are and how well they are tolerated when they are administered to healthy volunteers. Immediate-release and modified-release tablets contain the same active ingredient, but the modified-release tablet is covered with a protective layer, so it will dissolve in the intestines and not in the stomach. GLPG3312 has not been administered to humans before. Next to assessing the safety and tolerability, the purpose of this study is to investigate how food affects how quickly and to what extent GLPG3312 in a modified release formulation is absorbed and eliminated from the body. In addition, the effect of GLPG3312 on the body will be investigated by evaluating the effect of GLPG3312 on markers of the immune response.

Conditions: Healthy
Being tested: GLPG3312 IR, Placebo, GLPG3312 MR, GLPG3312 FE MR

What participants receive

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

GLPG3312 IRDrug
GLPG3312 IR tablets, up to 4 single ascending oral doses (A, B, C, D).
PlaceboDrug
Placebo tablets
GLPG3312 MRDrug
GLPG3312 MR film-coated tablets, up to 4 single ascending oral doses (H, I, J, K).
GLPG3312 FE MRDrug
GLPG3312 MR film-coated tablets, single oral dose (N) on 2 occasions, i.e. in fed state after a high-fat high-calorie breakfast, and in fasted state.
GLPG3312 MRDrug
GLPG3312 MR film-coated tablets, up to 2 multiple ascending oral doses (O, P).
GLPG3312 MRDrug
GLPG3312 MR optimized film-coated tablets, up to 3 multiple ascending oral doses (Q, R, S).
PlaceboDrug
Placebo optimized tablets

Study groups in NCT03800472
Study group	Role	What they receive
GLPG3312 SAD IR (Part 1)	Experimental	Single doses of GLPG3312 IR Receives: Drug: GLPG3312 IR
Placebo SAD IR (Part 1)	Placebo comparator	Single doses of Placebo IR Receives: Drug: Placebo
GLPG3312 SAD MR (Part 2)	Experimental	Single doses of GLPG3312 MR Receives: Drug: GLPG3312 MR
Placebo SAD MR (Part 2)	Placebo comparator	Single doses of Placebo MR Receives: Drug: Placebo
GLPG3312 FE MR (Part 3)	Experimental	Single dose of GLPG3312 MR in fed and fasted state Receives: Drug: GLPG3312 FE MR
GLPG3312 MAD MR (Part 4)	Experimental	Multiple doses of GLPG3312 MR Receives: Drug: GLPG3312 MR
Placebo MAD MR (Part 4)	Placebo comparator	Multiple doses of Placebo MR Receives: Drug: Placebo
GLPG3312 MAD MR optimized (Part 4)	Experimental	Multiple doses of GLPG3312 MR Receives: Drug: GLPG3312 MR
Placebo MAD MR optimized (Part 4)	Placebo comparator	Multiple doses of Placebo MR Receives: Drug: Placebo

What is being measured

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

Frequency and severity of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations
To evaluate the safety and tolerability of oral single and multiple ascending doses of GLPG3312, in adult, healthy, subjects, when given as Immediate Release (IR) formulation (in fasted conditions) or as Modified Release (MR) formulation (in fasted and fed conditions)
Measured: From screening through study completion, an average of 9 months.

Secondary outcomes (17)

Maximum observed plasma concentration (Cmax) of GLPG3312 (μg/mL) (Part 1)
To evaluate the pharmacokinetics (PK) of oral SAD of GLPG3312, in adult, healthy subjects, when given as IR formulation
Measured: Between Day 1 pre-dose and Day 4
Maximum observed plasma concentration (Cmax) of GLPG3312 (μg/mL) (Part 2)
To evaluate the pharmacokinetics (PK) of oral SAD of GLPG3312, in adult, healthy, subjects, when given as MR formulation
Measured: Between Day 1 pre-dose and Day 7
Maximum observed plasma concentration (Cmax) of GLPG3312 (μg/mL) under fed conditions (high-fat high calorie) versus fasted conditions (Part 3)
To evaluate the food effect on the PK of a single oral dose of GLPG3312 in adult, healthy, subjects, when given as MR formulation
Measured: Between Day 1 pre-dose and Day 7
Maximum observed plasma concentration (Cmax) of GLPG3312 (μg/mL) (Part 4)
To evaluate the pharmacokinetics (PK) of oral MAD of GLPG3312, in adult, healthy, subjects, when given as MR formulation
Measured: Between Day 1 pre-dose and Day 21
Area under curve (AUC) of GLPG3312 (μg.h/mL) (Part 1)
To evaluate the pharmacokinetics (PK) of oral SAD of GLPG3312, in adult, healthy, subjects, when given as IR formulation
Measured: Between Day 1 pre-dose and Day 4
Area under curve (AUC) of GLPG3312 (μg.h/mL) (Part 2)
To evaluate the pharmacokinetics (PK) of oral SAD of GLPG3312, in adult, healthy, subjects, when given as MR formulation
Measured: Between Day 1 pre-dose and Day 7
Area under curve (AUC) of GLPG3312 (μg.h/mL) under fed conditions (high-fat high calorie) versus fasted conditions (Part 3)
To evaluate the food effect on the PK of a single oral dose of GLPG3312 in adult, healthy, subjects, when given as MR formulation
Measured: Between Day 1 pre-dose and Day 7
Area under curve (AUC) of GLPG3312 (μg.h/mL) (Part 4)
To evaluate the pharmacokinetics (PK) of oral MAD of GLPG3312, in adult, healthy, subjects, when given as MR formulation
Measured: Between Day 1 pre-dose and Day 21
Terminal elimination half-life (t1/2) of GLPG3312 (h) (Part 1)
To evaluate the pharmacokinetics (PK) of oral SAD of GLPG3312, in adult, healthy, subjects, when given as IR formulation
Measured: Between Day 1 pre-dose and Day 4
Terminal elimination half-life (t1/2) of GLPG3312 (h) (Part 2)
To evaluate the pharmacokinetics (PK) of oral SAD of GLPG3312, in adult, healthy, subjects, when given as MR formulation
Measured: Between Day 1 pre-dose and Day 7
Terminal elimination half-life (t1/2) of GLPG3312 (h) (Part 4)
To evaluate the pharmacokinetics (PK) of oral MAD of GLPG3312, in adult, healthy, subjects, when given as MR formulation
Measured: Between Day 1 pre-dose and Day 21
Cumulative amount of GLPG3312 excreted in urine (Aeurine)(mg) (Part 1)
To evaluate the pharmacokinetics (PK) of oral SAD of GLPG3312, in adult, healthy subjects, when given as IR formulation
Measured: Between Day 1 pre-dose and Day 4
Cumulative amount of GLPG3312 excreted in urine (Aeurine)(mg) (Part 2)
To evaluate the pharmacokinetics (PK) of oral SAD of GLPG3312, in adult, healthy, subjects, when given as MR formulation
Measured: Between Day 1 pre-dose and Day 7
Cumulative amount of GLPG3312 excreted in urine (Aeurine)(mg) (Part 4)
To evaluate the PK of single and multiple ascending oral doses of GLPG3312, in adult, healthy subjects, when given as MR formulation.
Measured: Between Day 1 pre-dose and Day 21
Cumulative amount of GLPG3312 excreted in feces (Aefeces)(mg) (Part 4)
To evaluate the PK of single and multiple ascending oral doses of GLPG3312, in adult, healthy subjects, when given as MR formulation.
Measured: Between Day 1 pre-dose and Day 21
Ratio in extent and exposure following dosing of GLPG3312 as MR formulation compared to following dosing as IR formulation, under fasted conditions (Part 1 versus Part 2)
To evaluate the pharmacokinetics (PK) of oral SAD of GLPG3312, in adult, healthy, subjects, when given as IR or as MR formulation
Measured: Between Day 1 pre-dose and Day 4
Ratio in extent and exposure following dosing of GLPG3312 as MR tablets under fed conditions (high-fat high calorie) versus fasted conditions (Part 3)
To evaluate the food effect on the PK of a single oral dose of GLPG3312 in adult, healthy, subjects, when given as MR formulation
Measured: Between Day 1 pre-dose and Day 7

Timeline

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

15 Jan 201910 Mar 2020

First posted11 Jan 2019
Study start15 Jan 2019
Primary completion10 Mar 2020
Study completion10 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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: Randomised
Intervention model: Parallel groups
Model description: Part 1 (SAD IR), Part 2 (SAD MR) and Part 4 (MAD MR) are randomized, double-blind, placebo-controlled; Part 3 (FE MR) is open-label.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03800472
Sponsor's protocol ID: GLPG3312-CL-101
Other IDs: 2018-001955-11, 2018
Status last verified: Mar 2020
First submitted: 3 Jan 2019
Last updated: 19 Mar 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Temal-Laib T, Peixoto C, Desroy N, De Lemos E, Bonnaterre F, Bienvenu N, Picolet O, Sartori E, Bucher D, Lopez-Ramos M, Roca Magadan C, Laenen W, Flower T, Mollat P, Bugaud O, Touitou R, Pereira Fernandes A, Lavazais S, Monjardet A, Borgonovi M, Gosmini R, Brys R, Amantini D, De Vos S, Andrews M. Optimization of Selectivity and Pharmacokinetic Properties of Salt-Inducible Kinase Inhibitors that Led to the Discovery of Pan-SIK Inhibitor GLPG3312. J Med Chem. 2024 Jan 11;67(1):380-401. doi: 10.1021/acs.jmedchem.3c01428. Epub 2023 Dec 26.
PubMed 38147525

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?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Single-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Including the Effect of Food, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG3312, in Adult, Healthy Subjects
ClinicalTrials.gov ID: NCT03800472
Acronym / sponsor ID: GLPG3312-CL-101
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
Study start: 15 Jan 2019 (actual)
Primary completion: 10 Mar 2020 (actual)
Study completion: 10 Mar 2020 (actual)
First posted: 11 Jan 2019 (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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 9
Model description: Part 1 (SAD IR), Part 2 (SAD MR) and Part 4 (MAD MR) are randomized, double-blind, placebo-controlled; Part 3 (FE MR) is open-label.

Arm	Type	Receives
GLPG3312 SAD IR (Part 1)	Experimental	Drug: GLPG3312 IRSingle doses of GLPG3312 IR
Placebo SAD IR (Part 1)	Placebo comparator	Drug: PlaceboSingle doses of Placebo IR
GLPG3312 SAD MR (Part 2)	Experimental	Drug: GLPG3312 MRSingle doses of GLPG3312 MR
Placebo SAD MR (Part 2)	Placebo comparator	Drug: PlaceboSingle doses of Placebo MR
GLPG3312 FE MR (Part 3)	Experimental	Drug: GLPG3312 FE MRSingle dose of GLPG3312 MR in fed and fasted state
GLPG3312 MAD MR (Part 4)	Experimental	Drug: GLPG3312 MRMultiple doses of GLPG3312 MR
Placebo MAD MR (Part 4)	Placebo comparator	Drug: PlaceboMultiple doses of Placebo MR
GLPG3312 MAD MR optimized (Part 4)	Experimental	Drug: GLPG3312 MRMultiple doses of GLPG3312 MR
Placebo MAD MR optimized (Part 4)	Placebo comparator	Drug: PlaceboMultiple doses of Placebo MR

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 to 55 years of age (extremes included), on the date of signing the Informed Consent Form (ICF). Female should be of non-childbearing potential defined as permanently surgically sterile (bilateral oophorectomy, i.e. surgical removal of ovaries, bilateral salpingectomy or hysterectomy, i.e. surgical removal of uterus), or with no menses for 12 or more months without an alternative medical cause AND a folliclestimulating hormone (FSH) level >35 IU/L. These subjects must also have a negative pregnancy test. For surgical sterilization, documented confirmation will be requested.
A body mass index (BMI) between 18 to 30 kg/m2, inclusive.
Subject must be able and willing to comply with restrictions on prior medication.
Male subjects with female partners of childbearing potential must be willing to comply with contraceptive methods.
Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and fasting clinical laboratory safety tests. Clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered nonclinically significant in the opinion of the investigator. At minimum hemoglobin, alanine aminotransferase (ALT), creatinine, creatine kinase-myoglobin (CK-MB), High Sensitivity Troponin I, Troponin T and alkaline phosphatase must be within the normal range, aspartate aminotransferase (AST) must be no greater than 1.5x upper limit of normal range (ULN).

Key exclusion criteria (15 listed)

Known hypersensitivity to IMP ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator.
Positive serology for 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 the IMP.
History of, or a current immunosuppressive condition (e.g. HIV infection).
Having any illness (e.g. active allergy, fever, hypersensitivity reactions) judged by the investigator as clinically significant, in the 3 months prior to first dosing of the IMP.
Any history, or current sign or symptom of a cardiovascular, renal, or metabolic bone disease or disease of bone remodelling (with the exception of uncomplicated accidental bone fractures that recovered uncompromised at least 1 year ago), or any history of endocrine disease, including an abnormal laboratory result for prespecified clinical laboratory safety parameters related to these conditions.

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
GLPG3312 IRGLPG3312 IR tablets, up to 4 single ascending oral doses (A, B, C, D).	Drug	GLPG3312 SAD IR (Part 1)
PlaceboPlacebo tablets	Drug	Placebo MAD MR (Part 4), Placebo SAD IR (Part 1), Placebo SAD MR (Part 2)
GLPG3312 MRGLPG3312 MR film-coated tablets, up to 4 single ascending oral doses (H, I, J, K).	Drug	GLPG3312 SAD MR (Part 2)
GLPG3312 FE MRGLPG3312 MR film-coated tablets, single oral dose (N) on 2 occasions, i.e. in fed state after a high-fat high-calorie breakfast, and in fasted state.	Drug	GLPG3312 FE MR (Part 3)
GLPG3312 MRGLPG3312 MR film-coated tablets, up to 2 multiple ascending oral doses (O, P).	Drug	GLPG3312 MAD MR (Part 4)
GLPG3312 MRGLPG3312 MR optimized film-coated tablets, up to 3 multiple ascending oral doses (Q, R, S).	Drug	GLPG3312 MAD MR optimized (Part 4)
PlaceboPlacebo optimized tablets	Drug	Placebo MAD MR optimized (Part 4)

Primary outcome

Frequency and severity of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations
Time frame: From screening through study completion, an average of 9 months.
To evaluate the safety and tolerability of oral single and multiple ascending doses of GLPG3312, in adult, healthy, subjects, when given as Immediate Release (IR) formulation (in fasted conditions) or as Modified Release (MR) formulation (in fasted and fed conditions)

17 secondary outcomes

Maximum observed plasma concentration (Cmax) of GLPG3312 (μg/mL) (Part 1)
Time frame: Between Day 1 pre-dose and Day 4
Maximum observed plasma concentration (Cmax) of GLPG3312 (μg/mL) (Part 2)
Time frame: Between Day 1 pre-dose and Day 7
Maximum observed plasma concentration (Cmax) of GLPG3312 (μg/mL) under fed conditions (high-fat high calorie) versus fasted conditions (Part 3)
Time frame: Between Day 1 pre-dose and Day 7
Maximum observed plasma concentration (Cmax) of GLPG3312 (μg/mL) (Part 4)
Time frame: Between Day 1 pre-dose and Day 21
Area under curve (AUC) of GLPG3312 (μg.h/mL) (Part 1)
Time frame: Between Day 1 pre-dose and Day 4
Area under curve (AUC) of GLPG3312 (μg.h/mL) (Part 2)
Time frame: Between Day 1 pre-dose and Day 7
Area under curve (AUC) of GLPG3312 (μg.h/mL) under fed conditions (high-fat high calorie) versus fasted conditions (Part 3)
Time frame: Between Day 1 pre-dose and Day 7
Area under curve (AUC) of GLPG3312 (μg.h/mL) (Part 4)
Time frame: Between Day 1 pre-dose and Day 21
Terminal elimination half-life (t1/2) of GLPG3312 (h) (Part 1)
Time frame: Between Day 1 pre-dose and Day 4
Terminal elimination half-life (t1/2) of GLPG3312 (h) (Part 2)
Time frame: Between Day 1 pre-dose and Day 7
Terminal elimination half-life (t1/2) of GLPG3312 (h) (Part 4)
Time frame: Between Day 1 pre-dose and Day 21
Cumulative amount of GLPG3312 excreted in urine (Aeurine)(mg) (Part 1)
Time frame: Between Day 1 pre-dose and Day 4
Cumulative amount of GLPG3312 excreted in urine (Aeurine)(mg) (Part 2)
Time frame: Between Day 1 pre-dose and Day 7
Cumulative amount of GLPG3312 excreted in urine (Aeurine)(mg) (Part 4)
Time frame: Between Day 1 pre-dose and Day 21
Cumulative amount of GLPG3312 excreted in feces (Aefeces)(mg) (Part 4)
Time frame: Between Day 1 pre-dose and Day 21
Ratio in extent and exposure following dosing of GLPG3312 as MR formulation compared to following dosing as IR formulation, under fasted conditions (Part 1 versus Part 2)
Time frame: Between Day 1 pre-dose and Day 4
Ratio in extent and exposure following dosing of GLPG3312 as MR tablets under fed conditions (high-fat high calorie) versus fasted conditions (Part 3)
Time frame: Between Day 1 pre-dose and Day 7

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 Mar 2020.
Derived from this study: PubMed 38147525Temal-Laib T, Peixoto C, Desroy N, De Lemos E, Bonnaterre F, Bienvenu N, Picolet O, Sartori E, Bucher D, Lopez-Ramos M, Roca Magadan C, Laenen W, Flower T, Mollat P, Bugaud O, Touitou R, Pereira Fernandes A, Lavazais S, Monjardet A, Borgonovi M, Gosmini R, Brys R, Amantini D, De Vos S, Andrews M. Optimization of Selectivity and Pharmacokinetic Properties of Salt-Inducible Kinase Inhibitors that Led to the Discovery of Pan-SIK Inhibitor GLPG3312. J Med Chem. 2024 Jan 11;67(1):380-401. doi: 10.1021/acs.jmedchem.3c01428. Epub 2023 Dec 26.

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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.

Magdalena Petkova, 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 GLPG3312 IR, GLPG3312 MR and GLPG3312 FE MR in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Netherlands.

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 15 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 Mar 2020. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?

Frequency and severity of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations (time frame: From screening through study completion, an average of 9 months.). 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 NCT03800472, which also lists 1 linked publication.

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 Mar 2020.