Trial · NCT00875446
First Time in Human Study of GSK1223249 in Amyotrophic Lateral Sclerosis
NCT00875446, Phase 1, Completed, GlaxoSmithKline
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. First Time in Human Study of GSK1223249 in Amyotrophic Lateral Sclerosis. Trials, record NCT00875446. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00875446
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- First Time in Human Study of GSK1223249 in Amyotrophic Lateral Sclerosis
- NCT number
- NCT00875446
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 76 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- PLACEBO, GSK1223249
- First posted
- 2009-04-03
- Last updated
- 2017-09-20
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse events, vital signs, standard physical examination, ECG and standard clinical laboratory tests (haematology and biochemistry). Evaluation of safety will include any adverse effects on Immunogenicity, ALSFRS-R, SVC, Muscle Strength and MUNE. | 12-16 Weeks | |
| Secondary | GSK1223249: Single dose PK (Part 1): AUC(0-∞), AUC(0-t), AUC(0-Week 4), %AUCex, Cmax, tlast, CL, Vss, MRT, λz and t½.Repeat dose PK (Part 2): GSK1223249 AUC(0-Week 4), Cmax and after the second dose, AUC(0-t), AUC(0-∞),λz and t½. | 12-16 Weeks | |
| Secondary | Presence of antibodies to GSK1223249 will be assessed in serum samples using immuno-electrochemiluminescent assay. | At least 16 weeks | |
| Secondary | ALSFRS-R scores, Manual Muscle Strength test and Slow Inspirational Vital Capacity (SVC) | 12-16Weeks | |
| Secondary | Motor Unit Number Estimation (MUNE) | 12-16 Weeks | |
| Secondary | Muscle biopsies for protein analysis, Immunohistochemistry (IHC), Transcriptomics. Blood for protein analysis and other biomarkers. | At least 16 weeks | |
| Secondary | Relationships between PK of GSK1223249 and relevant pharmacological endpoints | At least 16 weeks |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24841795 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00875446
GET https://conductscience.org/api/trials/v1/NCT00875446/registered