Human study PLS-00216
Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers With and Without Bendavia
Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.
Reports of this study
Every publication, registration and abstract describing this one study. Participants are counted once.
- Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers With and Without Bendaviaregistry entry · NCT01513200 (COMPLETED, no results posted, planned enrollment 12)
Design and participants
- Design
- Other design
- Population
- Healthy volunteers
- Conditions
- Healthy Volunteers
- Planned enrollment (registry)
- 12
- Enrolled
- 12
- Randomized
- Not reported
- Completed follow-up
- Not reported
Intervention and comparator
What each group received. Related peptides, analogs and combinations are never treated as the compound itself.
- UFH with Bendavia (intervention) · elamipretide · Bendavia (elamipretide) given with unfractionated heparin. The title indicates heparin pharmacodynamics were assessed with Bendavia. · Not reported assigned
- UFH without Bendavia (saline) (comparator) · Unfractionated heparin with sterile 0.9% saline for infusion instead of Bendavia. · placebo · Not reported assigned
What the authors reported
As stated in the sources. This is the authors’ account, not Peptide Library’s assessment.
Pharmacodynamic effects of unfractionated heparin
unclear outcome · surrogate · Not specified in the record beyond the title's reference to heparin pharmacodynamic effects
- No results reported.
Adverse events
None reported. That is not evidence of safety, and how safety was monitored isn’t described.
Peptide Library’s assessment
An automated assessment, made by AI separately from the authors’ conclusions and not reviewed by a person. How risk of bias is assessed.
Limitations
- selective reporting: The registry record shows the study as completed but has_results is false, so no outcome data are available.
- inappropriate population: Participants were healthy volunteers, not people with Barth syndrome, mitochondrial myopathy or any disease.
- small or imprecise: Only 12 participants were actually enrolled according to the registry.
- inappropriate endpoint: The stated focus is the pharmacodynamics of heparin (a drug interaction question), not clinical benefit of elamipretide.
- other: The record states neither the allocation method, blinding, arm structure nor the outcome measures; only the title and intervention list are available.
No risk-of-bias assessment has been published for this study’s results.
Claims this study informs
- Improves function in Barth syndrome: not eligible (wrong population) for “Muscle strength, exercise capacity and fatigue”
- Improves exercise capacity in primary mitochondrial myopathy: not eligible (wrong population) for “Six-minute walk distance and fatigue”
- Is safe for human administration: not eligible (insufficient data) for “Adverse events, including injection-site reactions, and discontinuations”
Where each value comes from
- arms: NCT NCT01513200, registry (interventions field) · extracted by AI (automated, not verified by a person)
- design: NCT NCT01513200, registry (phases and study_type fields) · extracted by AI (automated, not verified by a person)
- limitations: NCT NCT01513200, registry (has_results and status fields) · extracted by AI (automated, not verified by a person)
- outcomes: NCT NCT01513200, title (study title) · extracted by AI (automated, not verified by a person)
- participants: NCT NCT01513200, registry (enrollment and enrollment_type fields) · extracted by AI (automated, not verified by a person)
- population: NCT NCT01513200, registry (conditions field) · extracted by AI (automated, not verified by a person)
Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.
These assessments describe published research. Records marked automated were produced by AI under the published methodology and have not been reviewed by a person; they can contain errors. None of this is medical advice, not a statement about any product’s safety for human use, and not a regulatory approval. Peptide Library’s vendor and partner relationships play no part in them (editorial independence).