ketoconazole has been researched along with Migraine Disorders in 3 studies
1-acetyl-4-(4-{[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine : A dioxolane that is 1,3-dioxolane which is substituted at positions 2, 2, and 4 by imidazol-1-ylmethyl, 2,4-dichlorophenyl, and [para-(4-acetylpiperazin-1-yl)phenoxy]methyl groups, respectively.
Migraine Disorders: A class of disabling primary headache disorders, characterized by recurrent unilateral pulsatile headaches. The two major subtypes are common migraine (without aura) and classic migraine (with aura or neurological symptoms). (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)
| Excerpt | Relevance | Reference |
|---|---|---|
| "Dihydroergotamine (DHE), a proven migraine treatment, currently has product labeling warning against concomitant use of CYP3A4 inhibitors because of potential drug interactions." | 2.77 | Lack of drug interaction between the migraine drug MAP0004 (orally inhaled dihydroergotamine) and a CYP3A4 inhibitor in humans. ( Chang, J; Dodick, D; Febbraro, S; Forst, A; Kellerman, D; Kori, S; Taylor, G; Thomas, T; Wutann, L, 2012) |
| " Structure-3A4 MDI relationship studies culminated in the discovery of a difluoro analogue, (S)-N-[1-(4-fluoro-3-morpholin-4-ylphenyl)ethyl]-3-(4-fluoro-phenyl)acrylamide (2), as an orally bioavailable KCNQ2 opener free of CYP3A4 MDI." | 1.32 | Fluorine substitution can block CYP3A4 metabolism-dependent inhibition: identification of (S)-N-[1-(4-fluoro-3- morpholin-4-ylphenyl)ethyl]-3- (4-fluorophenyl)acrylamide as an orally bioavailable KCNQ2 opener devoid of CYP3A4 metabolism-dependent inhibiti ( Davis, CD; Dworetzky, S; Fitzpatrick, WC; Harden, D; He, H; Knox, RJ; Newton, AE; Philip, T; Polson, C; Sinz, MW; Sivarao, DV; Sun, LQ; Tertyshnikova, S; Weaver, D; Wu, YJ; Yeola, S; Zoeckler, M, 2003) |
| " The exercise aids in integrating all the knowledge across the drug development to suggest rationale dosing strategies; effectively communicating the impact of the prognostic factors to the clinicians/regulators; and protect against any intellectual losses due to development team changes." | 1.31 | Application of modeling and simulation to integrate clinical pharmacology knowledge across a new drug application. ( Gobburu, JV; Sekar, VJ, 2002) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 2 (66.67) | 29.6817 |
| 2010's | 1 (33.33) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
| Authors | Studies |
|---|---|
| Wu, YJ | 1 |
| Davis, CD | 1 |
| Dworetzky, S | 1 |
| Fitzpatrick, WC | 1 |
| Harden, D | 1 |
| He, H | 1 |
| Knox, RJ | 1 |
| Newton, AE | 1 |
| Philip, T | 1 |
| Polson, C | 1 |
| Sivarao, DV | 1 |
| Sun, LQ | 1 |
| Tertyshnikova, S | 1 |
| Weaver, D | 1 |
| Yeola, S | 1 |
| Zoeckler, M | 1 |
| Sinz, MW | 1 |
| Kellerman, D | 1 |
| Kori, S | 1 |
| Forst, A | 1 |
| Chang, J | 1 |
| Febbraro, S | 1 |
| Wutann, L | 1 |
| Thomas, T | 1 |
| Taylor, G | 1 |
| Dodick, D | 1 |
| Gobburu, JV | 1 |
| Sekar, VJ | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Phase I Evaluation of the Effect of Ketoconazole on the Pharmacokinetics and Safety of Dihydroergotamine Mesylate (DHE) Delivered by Oral Inhalation (MAP0004) in Healthy Volunteers Compared to DHE Delivered Intravenously (DHE 45®)[NCT01468558] | Phase 1 | 24 participants (Actual) | Interventional | 2010-07-31 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
The AUC(0-48) is the area under the plot of plasma concentration of drug against time after drug administration. Dihydroergotamine AUC(0-48) is reported in picograms times hour per milliliter (pg*h/ml). (NCT01468558)
Timeframe: 48 hours
| Intervention | pg*h/ml (Geometric Mean) |
|---|---|
| MAP0004 1.0mg | 3484.725 |
| MAP0004 1.0mg + Ketoconazole | 4070.611 |
| IV DHE 1.0mg | 9229.171 |
The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Dihydroergotamine is reported in picograms per milliliter (pg/ml). (NCT01468558)
Timeframe: 48 hours
| Intervention | pg/ml (Geometric Mean) |
|---|---|
| MAP0004 1.0mg | 2582.507 |
| MAP0004 1.0mg + Ketoconazole | 2495.100 |
| IV DHE 1.0mg | 27771.234 |
1 trial available for ketoconazole and Migraine Disorders
| Article | Year |
|---|---|
Lack of drug interaction between the migraine drug MAP0004 (orally inhaled dihydroergotamine) and a CYP3A4 inhibitor in humans.
Topics: 14-alpha Demethylase Inhibitors; Administration, Inhalation; Adult; Chemistry, Pharmaceutical; Cytoc | 2012 |
2 other studies available for ketoconazole and Migraine Disorders
| Article | Year |
|---|---|
Fluorine substitution can block CYP3A4 metabolism-dependent inhibition: identification of (S)-N-[1-(4-fluoro-3- morpholin-4-ylphenyl)ethyl]-3- (4-fluorophenyl)acrylamide as an orally bioavailable KCNQ2 opener devoid of CYP3A4 metabolism-dependent inhibiti
Topics: Administration, Oral; Animals; Biological Availability; Cell Line; Cinnamates; Cytochrome P-450 CYP3 | 2003 |
Application of modeling and simulation to integrate clinical pharmacology knowledge across a new drug application.
Topics: Computer Simulation; Drug Interactions; Drugs, Investigational; Humans; Investigational New Drug App | 2002 |