A Study in Healthy Volunteers to Compare Different Tablet Formulations of the Test Medicine, GLPG1972, Against the Current Tablet Formulation, and to Assess the Effect Food Has on One of the Test Medicines

Healthy Clinical Trial

Official title:

A Randomized, Open-label, Four-period, Single-dose Cross-over Study in Healthy Male Subjects to Assess the Relative Bioavailability of Two Candidate Tablet Formulations Versus the Current Tablet Formulation of GLPG1972 and to Assess the Food Effect of the Tablet Formulation Selected for Phase 3 in Period 4

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04137341
• Other study ID #: GLPG1972-CL-109
• Secondary ID: 2019-002144-25
• Status: Completed
• Phase: Phase 1
• Start date: October 9, 2019
• Est. completion date: December 13, 2019

Study information

• Verified date: January 2020
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The sponsor wants to investigate two new tablet formulations (recipes) of the test medicine, and how they are taken up by the body in comparison to the current tablet formulation (study periods 1 to 3). If one of the 2 new tablets has a more favourable profile than the current tablet in periods 1 to 3, the sponsor will then investigate the effect that food has on this new tablet in study period 4. However, if the new tablets do not have a more favourable profile than the current tablet, the food effect does not need to be investigated and study period 4 will not be needed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 13, 2019
• Est. primary completion date: December 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male between 18-55 years of age (extremes included), on the date of signing the informed consent form

• A body mass index (BMI) between 18.0-30.0 kg/m2, inclusive

• Judged to be in good health by the investigator based upon the results of 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 considered not clinically significant in the opinion of the investigator

• Subject must be able and willing to comply with restrictions on prior medication as described in the protocol

• Negative screen for drugs (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, tricyclic antidepressants) and alcohol

Exclusion Criteria:

• Known hypersensitivity to IMP ingredients or history of a significant allergic reaction to the investigational medicinal product (IMP) ingredients as determined by the investigator, and/or known sensitivity to IMP or the excipients (e.g. lactose). Hay fever is allowed unless active.

• Positive serology for hepatitis B virus surface antigen or hepatitis C virus or history of hepatitis from any cause with the exception of hepatitis A that was resolved at least 3 months prior to first IMP administration.

• History of or a current immunosuppressive condition (e.g. human immunodeficiency virus infection)

• Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first IMP administration.

• Presence or sequelae of gastrointestinal, liver, kidney (creatinine clearance =80 mL/min, using the Cockcroft-Gault formula: if calculated result is =80 mL/min, a 24-hour urine collection can be done) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG1972 - A
Film-coated tablet, formulation A
• GLPG1972 - B
Film-coated tablet, formulation B
• GLPG1972 - C
Film-coated tablet, formulation C

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences Limited	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-time curve from time zero until the time corresponding with the last observed quantifiable concentration calculated by the linear up (AUC0-t) ratio between tablet formulations	To assess the bioavailability of two candidate tablet formulations (Tablet B and Tablet C) relative to that of the current tablet formulation (Tablet A) of GLPG1972	From Day 1 pre-dose up to Day 4
Primary	Area under the plasma concentration-time curve from time zero to infinity (AUC0-8) ratio between tablet formulations	To assess the bioavailability of two candidate tablet formulations (Tablet B and Tablet C) relative to that of the current tablet formulation (Tablet A) of GLPG1972	From Day 1 pre-dose up to Day 4
Primary	Maximum observed plasma concentration (Cmax) ratio between tablet formulations	To assess the food effect of the selected Phase 3 tablet formulation (in case Tablet B or Tablet C) of GLPG1972	From Day 1 pre-dose up to Day 4
Primary	Area under the plasma concentration-time curve from time zero until the time corresponding with the last observed quantifiable concentration calculated by the linear up (AUC0-t) ratio between fed and fasted	To assess the food effect of the selected Phase 3 tablet formulation (in case Tablet B or Tablet C) of GLPG1972	From Day 1 pre-dose up to Day 4
Primary	Area under the plasma concentration-time curve from time zero to infinity (AUC0-8) ratio between fed and fasted	To assess the food effect of the selected Phase 3 tablet formulation (in case Tablet B or Tablet C) of GLPG1972	From Day 1 pre-dose up to Day 4
Primary	Maximum observed plasma concentration (Cmax) ratio between fed and fasted	To assess the bioavailability of two candidate tablet formulations (Tablet B and Tablet C) relative to that of the current tablet formulation (Tablet A) of GLPG1972	From Day 1 pre-dose up to Day 4
Secondary	The number of incidents of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs) and TEAEs leading to discontinuations	To evaluate the safety and tolerability of oral doses of GLPG1972 tablet formulations	From Day 1 through study completion, an average of 2 months