ISRCTN36145549
Completed
Phase 1
A phase 1, open-label trial to evaluate the effects of single and multiple doses, CYP3A4 inhibition, and food on the pharmacokinetics of terguride in healthy subjects with known CYP2D6 genotypes
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- CYP2D6 genotype
- Sponsor
- medac GmbH
- Enrollment
- 36
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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