NL-OMON49500
Completed
Not Applicable
A phase I, open-label, single-dose, randomized, cross-over, 3 parts study to evaluate in healthy subjects the relative bioavailability of eltrombopag new capsule formulation (CPS) in comparison to the reference marketed film-coated tablets (FCT) (Part 1), the pharmacokinetic comparability of eltrombopag CPS and marketed FCT (Part 2) and the effect of food on the pharmacokinetics of eltrombopag administered as CPS (Part 3) - Bioavailability eltrombopag CPS vs FCT
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis
- Enrollment
- 248
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Male and female subjects who are 18 to 55 years of age on the day of Informed
- •Consent signature
- •\- Subjects in good health condition as determined by no clinically significant
- •findings from medical history, physical examination, vital signs, and ECG, as
- •well as laboratory values within the reference range at the local laboratory,
- •unless deemed not clinically significant by the Investigator or designee
- •\- Body mass index (BMI) of 18\.0 to 29\.9 kg/m2, with body weight greater than or
- •equal to 50 kg for males and 45 kg for females and no more than 120 kg
Exclusion Criteria
- •\- A history or presence of clinically significant ECG abnormalities or a family
- •history or presence of prolonged QT\-interval syndrome
- •\- Presence of hepatitis B or C virus, or human immunodeficiency virus
- •\- Clinical evidence of renal disease or liver disease or liver injury
- •\- Any surgical or medical condition which might significantly alter the
- •absorption, distribution, metabolism or excretion of drugs, such as
- •gastrectomy, gastroenterosomy, bowel restriction or colecystectomy
- •\- Administration of CYP3A4/5 inhibitors or inducers within 4 weeks prior to
- •screening and until 2 weeks after EOT, for their potential interaction with
- •hormonal contraceptive methods
Outcomes
Primary Outcomes
Not specified
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