Weight gain is a common side effect of alectinib therapy. Semaglutide could be used as medical anti-obesity drug to prevent alectinib-induced weight gain. Since semaglutide delays gastric emptying, alectinib absorption may be influenced with a possible change in AUC. To test if semaglutide can be administered safely along with alectinib, without serious drug-drug interactions, a pharmacokinetic interaction-study is needed.
Conditions
Interventions
Trade Name: Ozempic
Product Name: Semaglutide
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Semaglutide
CAS Number: 910463-68-2
Concentration unit: mg milligram(s)
C
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Age: =18 years; • Able to understand the written information and willing to give informed consent; • Diagnosed with metastatic NSCLC and (are planned to) receive treatment with alectinib (Alecensa); • Use of alectinib of at least 14 days, to guarantee steady-state, and expected to continue treatment until end of study period; • WHO performance score with a maximum of 2; • Willing to follow dietary restrictions. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Unable to draw blood for study purposes; • Pregnant or lactating women; • Not willing/able to not use medication which are a substrate for Pgp and have a small therapeutic window during study period, e.g. digoxine, dabigatran, sirolimus, everolimus, topotecan, nilotinib and lapatinib. Due to P-gp inhibition of alectinib; • Not willing/able to not use medication which are a substrate for Pgp and have a small therapeutic window during study period, e.g. rosuvastatine, sulfasalazine, methotrexaat, topotecan, lapatinib and mitoxantron. Due to BRCP inhibition of alectinib; • Unwillingness to abstain from any other food or drinks than the prescribed restrictions 1 hour before and 2 hours after intake of alectinib at the pharmacokinetic sampling day; • Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria); • Allergic to compounds in yoghurt.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test if there is a significant drug-drug interaction between alectinib and semaglutide.;Secondary Objective: Not applicable;Primary end point(s): Test of significant difference in trough concentration between patients with and without semaglutide co-administration.;Timepoint(s) of evaluation of this end point: 1 week after administration of subcutaneous semaglutide | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Netherlands
Outcome results
None listed