A Healthy Volunteer Study to Investigate the Relative Bioavailability of Two Forms of GSK598809 Capsules.
2. august 2017 oppdatert av: GlaxoSmithKline
An Open Label, Randomised, Single Dose, Three-way Crossover Study to Investigate the Relative Bioavailability of a 100mg Capsule Compared to Four 25mg GSK598809 Capsules and the Effect of Food on the Pharmacokinetics of the 100mg Capsule in Healthy Male and Female Volunteers.
Study to compare PK of a new 100mg capsule with four 25mg capsules.
This is required because we plan to have only single capsules administered in the later phase clinical trials but we have not had a 100mg strength before.
As this is a new previously untested strength we need to ensure that the PK is similar to that achieved using 4 x 25mg.
The study will also assess the effect of high fat food on the PK of the 100mg capsule.
The study is planned to consist of a single part , with three dosing periods, periods 1-3 consisting of 16 subjects.
There will be a week wash out between each dose.
In the three dosing periods subjects will either received 4x25 mg GSK598809 capsule in a fasted state, 100mg capsule in a fasted state or 100mg GSK598809 capsule in a fed state.
Subjects will return to the centre for follow-up 7-14 days after the final dose.
It is expected that the total duration of the study should be approximately eight weeks.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
16
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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London, Storbritannia, SE1 1YR
- GSK Investigational Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion:
- Healthy as determined by responsible physician.
- Male or female between 18 to 65 years old.
- Females of non-child bearing potential and females of child-bearing potential that agree to use appropriate method of contraception for appropriate amount of time.
- Males that agree to use appropriate method of contraception for appropriate amount of time.
- Neither too fat nor too thin.
- Capable of giving written informed consent and being compliant with requirements within the informed consent.
Exclusion:
- Any current medical or psychiatric illness.
- Any history of chronic medical or psychiatric illnesses.
- Previous or current alcohol or drug abuse/dependence including nicotine.
- Female subjects must not be breastfeeding or been breastfeeding for a month.
- Serum prolactin exceeding normal range.
- Personal or family history of prolonged QTc syndrome.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Subjects receiving treatment sequence ABC
Eligible subjects will receive treatment sequence ABC; A= 4x25 milligrams GSK598809 capsule given in fasted state, B= 100 milligrams GSK598809 capsule in given fasted state and C= 100 milligrams GSK598809 capsule given in fed state.
The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
|
GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.
GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.
|
|
Eksperimentell: Subjects receiving treatment sequence ACB
Eligible subjects will receive treatment sequence ACB; A= 4x25 milligrams GSK598809 capsule given in fasted state, C= 100 milligrams GSK598809 capsule given in fed state and B= 100 milligrams GSK598809 capsule in given fasted state.
The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
|
GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.
GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.
|
|
Eksperimentell: Subjects receiving treatment sequence BAC
Eligible subjects will receive treatment sequence BAC; B= 100 milligrams GSK598809 capsule in given fasted state, A= 4x25 milligrams GSK598809 capsule given in fasted state and C= 100 milligrams GSK598809 capsule given in fed state.
The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
|
GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.
GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.
|
|
Eksperimentell: Subjects receiving treatment sequence BCA
Eligible subjects will receive treatment sequence BCA; B= 100 milligrams GSK598809 capsule in given fasted state, C= 100 milligrams GSK598809 capsule given in fed state and A= 4x25 milligrams GSK598809 capsule given in fasted state.
The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
|
GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.
GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.
|
|
Eksperimentell: Subjects receiving treatment sequence CAB
Eligible subjects will receive treatment sequence CAB; C= 100 milligrams GSK598809 capsule given in fed state, A= 4x25 milligrams GSK598809 capsule given in fasted state and B= 100 milligrams GSK598809 capsule in given fasted state.
The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
|
GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.
GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.
|
|
Eksperimentell: Subjects receiving treatment sequence CBA
Eligible subjects will receive treatment sequence CBA; C= 100 milligrams GSK598809 capsule given in fed state, B= 100 milligrams GSK598809 capsule in given fasted state and A= 4x25 milligrams GSK598809 capsule given in fasted state.
The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
|
GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.
GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Blood sampling over a period of 96hrs post GSK598809 dosing in the three dosing periods.
Tidsramme: Pre-dose, 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8. 10, 12, 16, 24, 48. 72 and 96 hours
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Pre-dose, 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8. 10, 12, 16, 24, 48. 72 and 96 hours
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Safety and Tolerability: cardiovascular variables, vital signs, clinical labs, movement scales, prolactin, GH and TSH levels over 96 hours post dosing. Continuous adverse event monitoring from dosing until study conclusions.
Tidsramme: Up to 96 hours
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Up to 96 hours
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
2. juli 2008
Primær fullføring (Faktiske)
29. juli 2008
Studiet fullført (Faktiske)
29. juli 2008
Datoer for studieregistrering
Først innsendt
4. august 2008
Først innsendt som oppfylte QC-kriteriene
4. august 2008
Først lagt ut (Anslag)
6. august 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. august 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. august 2017
Sist bekreftet
1. august 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DAN111283
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