CYP2D6 genotype Genetic Diseases CYP2D6 genotype
Conditions
Interventions
The study takes place in three parts. Administered doses will depend on genotype and tolerability by the subject. Initial doses in Part 1 are 0.75 mg, 1.5 mg, 2.5 mg and 3.0 mg terguride in PM, IM, EM
Sponsors
medac GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Medically healthy adults 2. Aged between 18-60 years inclusive at the time of screening 3. Non-smoker 4. Body mass index (BMI) = 18.5 and = 30.0 kg/m2 at screening 5. Known CYP2D6 genotype 6. No clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI 7. Appropriate contraception 8. Able to swallow multiple capsules and/or tablets 9. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol
Exclusion criteria
Exclusion criteria: 1. Mentally or legally incapacity 2. History or presence of clinically significant medical or psychiatric condition or disease 3. Alcoholism or drug abuse within the past 2 years 5. History or presence of hypersensitivity or idiosyncratic reaction to the study drug, itraconazole, metoclopramide (MCP) or related compounds 6. Female subjects who are pregnant or lactating 7. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or antihepatitis C virus (antiHCV) antibodies screen 8. QTcF interval is >450 msec (males) or >470 msec (females) or clinically significant ECG findings at screening 9. Creatinine clearance < 80 mL/min 10. Drugs / herbals known to be significant inducers of CYP enzymes and/or P-gp 11. Diet incompatible with the on-study diet, lactose intolerance 12. Major surgery within 60 days prior to the first dose of study drug and throughout the study 13. Donation of blood or plasma within 90 days prior to the first dose of study drug 14. Donation of bone marrow within the last 6 months prior to the first dose of study drug 15. Participation in another clinical trial within 90 days prior to the first dose of study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum concentration (Cmax) and area under the plasma concentration curve (AUC) of terguride is measured using blood analysis and uranlysis: Part one: Study days 1, 3, 5, and 7 Part two: Study days 12 and 17 Part three: Study days 10 and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cmax and AUC of N’-monodesethyl-terguride, measured using blood analysis and uranlysis: Part one: Study days 1, 3, 5, and 7 Part two: Study days 12 and 17 Part three: Study days 10 and 12 2. Heart rate-corrected QT interval (QTcF) determined using EEG scanning in part one only, on study days 1, 3, 5, and 7 | — |
Countries
United Kingdom
Outcome results
None listed