adenine has been researched along with Congenital Zika Syndrome in 3 studies
| Excerpt | Relevance | Reference |
|---|---|---|
| "Galidesivir (BCX4430) is an adenosine nucleoside analog broadly active in cell culture against multiple RNA virus families, and active in animal models of viral diseases associated with Ebola, Marburg, yellow fever, Zika, and Rift Valley fever." | 3.11 | Pharmacokinetics and Safety of the Nucleoside Analog Antiviral Drug Galidesivir Administered to Healthy Adult Subjects. ( Collins, D; Dobo, S; Mathis, A; Sheridan, WP; Taylor, R; Walling, DM, 2022) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 1 (33.33) | 24.3611 |
| 2020's | 2 (66.67) | 2.80 |
| Authors | Studies |
|---|---|
| Abrams, RPM | 1 |
| Yasgar, A | 1 |
| Teramoto, T | 1 |
| Lee, MH | 1 |
| Dorjsuren, D | 1 |
| Eastman, RT | 1 |
| Malik, N | 1 |
| Zakharov, AV | 1 |
| Li, W | 1 |
| Bachani, M | 1 |
| Brimacombe, K | 1 |
| Steiner, JP | 1 |
| Hall, MD | 1 |
| Balasubramanian, A | 1 |
| Jadhav, A | 1 |
| Padmanabhan, R | 1 |
| Simeonov, A | 1 |
| Nath, A | 1 |
| Mathis, A | 1 |
| Collins, D | 1 |
| Dobo, S | 1 |
| Walling, DM | 1 |
| Sheridan, WP | 2 |
| Taylor, R | 2 |
| Julander, JG | 1 |
| Siddharthan, V | 1 |
| Evans, J | 1 |
| Tolbert, K | 1 |
| Apuli, C | 1 |
| Stewart, J | 1 |
| Collins, P | 1 |
| Gebre, M | 1 |
| Neilson, S | 1 |
| Van Wettere, A | 1 |
| Lee, YM | 1 |
| Morrey, JD | 1 |
| Babu, YS | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Phase 1 Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Galidesivir (BCX4430) Administered as Single Doses Via Intravenous Infusion in Healthy Subjects[NCT03800173] | Phase 1 | 32 participants (Actual) | Interventional | 2018-12-10 | Completed | ||
| A Phase 1 Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BCX4430 Administered Via Intramuscular Injection (IM) in Healthy Subjects[NCT02319772] | Phase 1 | 94 participants (Actual) | Interventional | 2014-12-31 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Urine was collected from subjects over a 96 hour period per protocol, analyzed for galidesivir concentrations. Urine PK parameters including CLR (renal clearance of unchanged drug cumulatively over all collection intervals or in a specific interval) were estimated in SAS for Windows v9.4 or higher (SAS Institute, Inc.) based on the recorded urine concentrations and volumes. (NCT03800173)
Timeframe: Urine PK parameters are based on sampling over a 96 hour period.
| Intervention | L/hr (Geometric Mean) |
|---|---|
| 5 mg/kg Galidesivir | 9.305 |
| 10 mg/kg Galidesivir | 11.66 |
| 15 mg/kg Galidesivir | 11.51 |
| 20 mg/kg Galidesivir | 7.131 |
"Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:~Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose.~Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)~Day 21 (+2 days) or early termination.~Cmax for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.)." (NCT03800173)
Timeframe: Plasma PK parameters are based on sampling over a 21 day period
| Intervention | ng/mL (Geometric Mean) |
|---|---|
| 5 mg/kg Galidesivir | 5540 |
| 10 mg/kg Galidesivir | 10300 |
| 15 mg/kg Galidesivir | 17730 |
| 20 mg/kg Galidesivir | 20490 |
Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). (NCT03800173)
Timeframe: AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up period, up to 23 days from IMP dosing on Day 1.
| Intervention | participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Subjects with at least 1 TEAE | Not related TEAEs | Related TEAEs | Mild TEAE | Moderate TEAE | Severe TEAE | Subjects with at least 1 SAE | Subject Discontinuation due to AE | |
| 10 mg/kg Galidesivir | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 0 |
| 15 mg/kg Galidesivir | 4 | 2 | 2 | 3 | 0 | 1 | 1 | 0 |
| 20 mg/kg Galidesivir | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| 5 mg/kg Galidesivir | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Placebo | 2 | 2 | 0 | 2 | 0 | 0 | 0 | 0 |
"Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:~Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose.~Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)~Day 21 (+2 days) or early termination.~AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where t = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.)." (NCT03800173)
Timeframe: Plasma PK parameters are based on sampling over a 21 day period
| Intervention | ng*h/mL (Geometric Mean) | |
|---|---|---|
| AUC0-inf | AUC0-t | |
| 10 mg/kg Galidesivir | 37080 | 32360 |
| 15 mg/kg Galidesivir | 65860 | 59590 |
| 20 mg/kg Galidesivir | 81230 | 73350 |
| 5 mg/kg Galidesivir | 21160 | 17150 |
1 trial available for adenine and Congenital Zika Syndrome
| Article | Year |
|---|---|
Pharmacokinetics and Safety of the Nucleoside Analog Antiviral Drug Galidesivir Administered to Healthy Adult Subjects.
Topics: Adenine; Adenosine; Animals; Antiviral Agents; Healthy Volunteers; Humans; Nucleosides; Pyrrolidines | 2022 |
Pharmacokinetics and Safety of the Nucleoside Analog Antiviral Drug Galidesivir Administered to Healthy Adult Subjects.
Topics: Adenine; Adenosine; Animals; Antiviral Agents; Healthy Volunteers; Humans; Nucleosides; Pyrrolidines | 2022 |
Pharmacokinetics and Safety of the Nucleoside Analog Antiviral Drug Galidesivir Administered to Healthy Adult Subjects.
Topics: Adenine; Adenosine; Animals; Antiviral Agents; Healthy Volunteers; Humans; Nucleosides; Pyrrolidines | 2022 |
Pharmacokinetics and Safety of the Nucleoside Analog Antiviral Drug Galidesivir Administered to Healthy Adult Subjects.
Topics: Adenine; Adenosine; Animals; Antiviral Agents; Healthy Volunteers; Humans; Nucleosides; Pyrrolidines | 2022 |
2 other studies available for adenine and Congenital Zika Syndrome
| Article | Year |
|---|---|
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
Topics: Animals; Antiviral Agents; Artificial Intelligence; Chlorocebus aethiops; Disease Models, Animal; Dr | 2020 |
Efficacy of the broad-spectrum antiviral compound BCX4430 against Zika virus in cell culture and in a mouse model.
Topics: Adenine; Adenosine; Animals; Antiviral Agents; Brain; Cell Line; Disease Models, Animal; Humans; Mal | 2017 |