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Clinical Trials/NL-OMON50753
NL-OMON50753
Completed
Not Applicable

An open-label study to investigate the effects of emvododstat on the pharmacokinetics of CYP2D6 and BCRP substrates in healthy volunteers - Emvododstat (PTC299) DDI study with CYP2D6 and BCRP substrates

PTC Therapeutics, Inc.0 sites36 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
PTC Therapeutics, Inc.
Enrollment
36
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Healthy adult, non\-smokers (no use of tobacco products within 6 months prior
  • •to Screening), \>\=18 and \<\=65 years of age.
  • •2\. Body mass index \>18\.0 and \<30\.0 kg/m2 and body weight \>\=50\.0 kg and \<\=110\.0 kg.
  • •3\. Ability to swallow tablets
  • •4\. Women of child\-bearing potential (as defined in (CTFG 2014\)) must have a
  • •negative pregnancy test at Screening and agree to abstinence or the use at
  • •least one of the following highly effective forms of contraception (with a
  • •failure rate of \<1% per year when used consistently and correctly) in addition
  • •to barrier method for their sexual partner. Contraception or abstinence must be
  • •continued for the duration of the study following discharge from the hospital,

Exclusion Criteria

  • •1\. For Part 1 (CYP2D6 substrate), subjects who are poor metabolizers of CYP2D6
  • •isoenzymes are excluded.
  • •2\. Pregnant or lactating subjects or those sexually active subjects who are
  • •unwilling to comply with proper birth control methods; females of child\-bearing
  • •potential must have a negative pregnancy test at Screening and during the
  • •Baseline Visit.
  • •3\. Aspartate aminotransferase or alanine aminotransferase above the upper limit
  • •of normal (ULN) at the time of Screening or Baseline. Values above ULN may be
  • •allowed if considered not clinically significant at the discretion of the
  • •Investigator.

Outcomes

Primary Outcomes

Not specified

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