Pharmacokinetics of terguride in healthy subjects with known CYP2D6 genotype

Phase 1

Completed

• Conditions: CYP2D6 genotype; Genetic Diseases

• Registration Number: ISRCTN36145549
• Lead Sponsor: medac GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-01
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified