Trial reportThe Journal of antimicrobial chemotherapy2024
First-in-human study of alpibectir (BVL-GSK098), a novel potent anti-TB drug.
Trial report in The Journal of antimicrobial chemotherapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04654143 (A Phase I, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics and Food Effect of BVL-GSK098 Administered as Single and Multiple Oral Doses to Healthy Volunteers), which is not on this map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase I, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics and Food Effect of BVL-GSK098 Administered as Single and Multiple Oral Doses to Healthy Volunteers
Who cites it
5 citing papers in PubMed, 8 citations in OpenAlex.
- Ethionamide versus ethambutol-containing first-line regimens for TB meningitis.Antimicrobial agents and chemotherapy · 2026Article
- Alpibectir-Ethionamide combination (AlpE) for the treatment of tuberculosis.Nature communications · 2026Article
- Revival of Ethionamide by Alpibectir.The New England journal of medicine · 2026Article
- New drugs for the management of tuberculosis.Current opinion in infectious diseases · 2025Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 6 institutions in 4 countries.
Funding
Abstract
backgroundThe clinical candidate alpibectir augments the activity of, and overcomes resistance to, the anti-TB drug ethionamide in vitro and in vivo.
objectivesA Phase 1, double-blind, randomized, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (PK) and food effect of alpibectir administered as single and multiple oral doses in healthy volunteers (NCT04654143).
methodsEighty participants were randomized. In single ascending dose (SAD), a total of six dose levels of alpibectir (0.5 to 40 mg) were tested under fasted and fed (10 mg) conditions as single daily doses in sequential cohorts. In multiple ascending dose (MAD), repeat doses (5 to 30 mg) were administered once daily for 7 days in three sequential cohorts.
resultsNo serious adverse event was reported. Thirteen participants across groups experienced a total of 13 mild or moderate treatment-emergent adverse events. Alpibectir showed rapid absorption after single dose (mean Tmax range of 0.88 to 1.53 h). Food affected the PK of alpibectir, characterized by a slower absorption (mean Tmax 3.87 h), a lower Cmax (-17.7%) and increased AUC0-t (+19.6%) compared with the fasted condition. Following repeat dosing, dose proportionality was shown for both Cmax and AUC0-tau. Accumulation of alpibectir was observed across all doses, with a more profound effect on AUC during a dosing interval (AUC0-tau) compared with Cmax (1.8- and 1.3-fold on average), respectively. Steady state was considered to have been achieved by Day 7 of dosing.
conclusionsAlpibectir was generally well tolerated, and no clinically relevant safety findings were identified in the participants treated during SAD or MAD. The PK is dose-proportional and affected by food.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.