Peptide Library

Human study PLS-00219

Safety and Pharmacokinetic (PK) Study of Oral Bendavia Administered for 7 Days

Other design · 30 participants enrolled

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.

  • Safety and Pharmacokinetic (PK) Study of Oral Bendavia Administered for 7 Daysregistry entry · NCT01786915 (COMPLETED, no results posted, planned enrollment 30)

Design and participants

Design
Other design
Population
Healthy volunteers
Conditions
Healthy Volunteers
Planned enrollment (registry)
30
Enrolled
30
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.

  • Oral Bendavia dose group A (intervention) · elamipretide · Oral Bendavia (MTP-131, elamipretide), one of two dose groups listed in the registry · oral · 7 days · Not reported assigned
  • Oral Bendavia dose group B (intervention) · elamipretide · Oral Bendavia (MTP-131, elamipretide), the second of two dose groups listed in the registry · oral · 7 days · Not reported assigned
  • Placebo (comparator) · Placebo · placebo · oral · 7 days · Not reported assigned

What the authors reported

As stated in the sources. This is the authors’ account, not Peptide Library’s assessment.

Safety (adverse events)

primary outcome · safety · 7 days of dosing · Not specified in the record; safety is named in the study title

  • No results reported.

Pharmacokinetics

primary outcome · surrogate · 7 days of dosing · Not specified in the record; pharmacokinetics is named in the study title

  • No results reported.

Adverse events

None reported. That is not evidence of safety.

Monitoring: Not described in the record beyond the title's stated focus on safety.

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

  • other: Method of allocation (randomization) and blinding are not stated in the registry record.
  • selective reporting: The study is listed as completed but has no results posted, raising concern about non-reporting.
  • small or imprecise: Only 30 participants were enrolled across three groups, limiting precision for safety signals.
  • short follow up: Dosing lasted 7 days per the title, too short to capture longer-term adverse effects.
  • inappropriate population: Healthy volunteers do not represent people with Barth syndrome or primary mitochondrial myopathy.

No risk-of-bias assessment has been published for this study’s results.

Claims this study informs

Where each value comes from

  • arms: NCT NCT01786915, registry (interventions field) · extracted by AI (automated, not verified by a person)
  • arms: NCT NCT01786915, title (oral administration for 7 days) · extracted by AI (automated, not verified by a person)
  • design: NCT NCT01786915, registry (phases and study_type fields) · extracted by AI (automated, not verified by a person)
  • outcomes: NCT NCT01786915, title (safety and pharmacokinetic aims) · extracted by AI (automated, not verified by a person)
  • participants: NCT NCT01786915, registry (enrollment and enrollment_type fields) · extracted by AI (automated, not verified by a person)
  • population: NCT NCT01786915, 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).