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A Dose-escalating Clinical Trial With KH176

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ClinicalTrials.gov Identifier: NCT02544217
Recruitment Status : Completed
First Posted : September 9, 2015
Last Update Posted : February 8, 2016
Sponsor:
Collaborator:
Drug Research Unit Ghent, Belgium
Information provided by (Responsible Party):
Khondrion BV

Tracking Information
First Submitted Date  ICMJE April 19, 2015
First Posted Date  ICMJE September 9, 2015
Last Update Posted Date February 8, 2016
Study Start Date  ICMJE May 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2015)
  • Safety and tolerability (assessment of adverse events, routine clinical laboratory, vital signs, ECG, physical exam) [ Time Frame: 4 months ]
    assessment of adverse events, routine clinical laboratory, vital signs, ECG, physical exam
  • Pharmacokinetics of KH176 [ Time Frame: 7 days ]
    assessment of time to reach peak plasma concentration
  • Pharmacokinetics of KH176 [ Time Frame: 7 days ]
    assessment of peak plasma concentration
  • Pharmacokinetics of KH176 [ Time Frame: 7 days ]
    assessment of the area under the plasma concentration versus time curve (AUC)
  • Pharmacokinetics of KH176 [ Time Frame: 7 days ]
    assessment of half life
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02544217 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2015)
Pharmacodynamics of KH176 [ Time Frame: 7 days ]
change from baseline in biochemistry related to OXPHOS (glutathione, lactate)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose-escalating Clinical Trial With KH176
Official Title  ICMJE A Phase I, Randomized, Double Blind, Placebo-controlled, Dose-escalating Clinical Trial With KH176
Brief Summary Mitochondrial Diseases are rare progressive, multi-system, often early fatal disorders affecting both children and adults. KH176 is a novel chemical entity currently under development for the treatment of inherited mitochondrial diseases, including MELAS (Mitochondrial Encephalomyopathy, Lactic acidosis, and Stroke-like episodes), Leigh's Disease and LHON (Leber's Hereditary Optic Neuropathy). KH176 is a potent intracellular redox modulating agent targeting the reactive oxygen species which are important in the pathogenesis of disorders of mitochondrial oxidative phosphorylation. After demonstrating a favourable safety profile in the pre-clinical testing, the safety, tolerability and pharmacokinetic and pharmacodynamic characteristics of the compound will now be evaluated in healthy male subjects in this trial
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • MELAS
  • LHON
  • Leigh Syndrome
  • Mitochondrial Disease
  • Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation
Intervention  ICMJE
  • Drug: KH176
  • Drug: placebo
Study Arms  ICMJE
  • Experimental: Single Escalating
    2 alternating groups receiving escalating single doses of active/placebo
    Interventions:
    • Drug: KH176
    • Drug: placebo
  • Experimental: Multiple Escalating
    3 multiple escalating groups, receiving active/placebo
    Interventions:
    • Drug: KH176
    • Drug: placebo
Publications * Koene S, Spaans E, Van Bortel L, Van Lancker G, Delafontaine B, Badilini F, Beyrath J, Smeitink J. KH176 under development for rare mitochondrial disease: a first in man randomized controlled clinical trial in healthy male volunteers. Orphanet J Rare Dis. 2017 Oct 16;12(1):163. doi: 10.1186/s13023-017-0715-0.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy as assessed by medical history, physical examination, Vital Signs, Clinical Laboratory, ECG

Exclusion Criteria:

  • Allergies,
  • Concomitant medication,
  • concomitant disease,
  • relevant surgery,
  • recent blood donation
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02544217
Other Study ID Numbers  ICMJE KH176-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Khondrion BV
Study Sponsor  ICMJE Khondrion BV
Collaborators  ICMJE Drug Research Unit Ghent, Belgium
Investigators  ICMJE Not Provided
PRS Account Khondrion BV
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP