Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:26 AM
Study NCT ID:
NCT07462234
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous N-of-1 Computational Feasibility Study of a Whole Genome Sequence
Sponsor:
Bioactify LLC
Organization:
Study Overview
Official Title:
Automated Hypothesis Generation Via Deterministic Bioenergetic Simulation of a Whole Genome Sequence: A Continuous N-of-1 Computational Feasibility Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
B2026N1
Brief Summary:
This is an observational, computational N-of-1 study that uses previously collected Whole Genome Sequencing (WGS) data from a single adult participant to evaluate the feasibility of a deterministic bioenergetic simulation model. The study does not involve clinical interventions, treatments, or prospective specimen collection. All analyses are performed on existing genomic data in a secure computational environment.
The purpose of this study is to determine whether a physics-based metabolic model can successfully integrate individual genomic constraints to generate personalized, hypothesis-driven insights about metabolic pathways. The study focuses on model feasibility and computational performance, not clinical outcomes. No medications, diets, or behavioral interventions are administered or evaluated.
The purpose of this study is to determine whether a physics-based metabolic model can successfully integrate individual genomic constraints to generate personalized, hypothesis-driven insights about metabolic pathways. The study focuses on model feasibility and computational performance, not clinical outcomes. No medications, diets, or behavioral interventions are administered or evaluated.
Detailed Description:
This protocol (B-2026-N1) describes a continuous, observational N-of-1 computational feasibility study conducted by Bioactify LLC and What Ifs Tech Inc. The study uses secondary, commercially obtained 30x Whole Genome Sequencing (WGS) data from a single adult participant. No new data are collected for research purposes, and no clinical interventions are performed.
The primary objective is to assess the feasibility of integrating static genomic constraints into a deterministic simulation engine that incorporates Flux Balance Analysis (FBA) and dynamic physiologically based modeling. The computational framework is designed to explore how individual genetic variants may influence metabolic pathway behavior. All analyses occur within an isolated cloud environment using pre-existing data.
This study is observational and exploratory. It does not evaluate the safety, efficacy, or clinical utility of any treatment, diet, medication, or device. The research aims to generate methodological insights about individualized computational modeling and hypothesis generation.
This study received an Exempt Research Determination from Pearl IRB (Protocol ID: 2026-0119) under 45 CFR 46.104(d)(4), as it involves only secondary use of existing data with no interaction or intervention with human subjects.
The primary objective is to assess the feasibility of integrating static genomic constraints into a deterministic simulation engine that incorporates Flux Balance Analysis (FBA) and dynamic physiologically based modeling. The computational framework is designed to explore how individual genetic variants may influence metabolic pathway behavior. All analyses occur within an isolated cloud environment using pre-existing data.
This study is observational and exploratory. It does not evaluate the safety, efficacy, or clinical utility of any treatment, diet, medication, or device. The research aims to generate methodological insights about individualized computational modeling and hypothesis generation.
This study received an Exempt Research Determination from Pearl IRB (Protocol ID: 2026-0119) under 45 CFR 46.104(d)(4), as it involves only secondary use of existing data with no interaction or intervention with human subjects.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: