NL-OMON54972
Completed
Not Applicable
Phase 1 Dose Escalation Study Assessing the Safety and Pharmacokinetics of PTC518 in Healthy Subjects - CS0349-200101 PTC518
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- PTC Therapeutics, Inc.
- Enrollment
- 136
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. For Part 1, Part 2, Part 4, and Part 5: Healthy male or female subjects aged
- •from 18 to 65 years old, inclusive, at Screening. For Part 3: healthy male of
- •female subjects aged 50 to 65 years old, inclusive, at Screening.
- •2\. Subjects must understand the nature of the study and must provide signed and
- •dated written informed consent before the conduct of any study\-related
- •procedures.
- •3\. Body Mass Index (BMI) of \>\=18\.5 kg/m2 and \<\=30\.0 kg/m2 with a body weight
- •\>\=50\.0 kg for male subjects and a body weight \>\=45\.0 kg for female subjects at
- •4\. Healthy as determined by the Investigator, based upon a medical evaluation
- •including medical history, physical examination, laboratory test results, ECG
Exclusion Criteria
- •1\. Subjects that participated in any drug or device clinical investigation
- •within 60 days prior to Screening or who anticipate participating in any drug
- •or device clinical investigation within the duration of this study.
- •2\. Prior or ongoing medical condition (e.g., concomitant illness, psychiatric
- •condition), medical history, physical findings that, in the Investigator\*s
- •opinion, could adversely affect the safety of the subject or could impair the
- •assessment of study results.
- •3\. An abnormal general neurological examination.
- •4\. Presence of any clinically significant abnormality during Screening.
- •5\. Any psychological, emotional problems, any disorders or resultant therapy
Outcomes
Primary Outcomes
Not specified
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