- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02606903
Pharmacokinetics and Safety of BI 695501 Administered Via Prefilled Syringe or Autoinjector
13. juni 2018 oppdatert av: Boehringer Ingelheim
Randomized, Single-dose, Parallel-arm, Open-label Phase I Trial to Investigate and Compare the Pharmacokinetics, Safety and Tolerability of BI 695501 Administered Subcutaneously Via Prefilled Syringe or Autoinjector
To investigate and compare the pharmacokinetics, safety and tolerability of BI 695501 administered subcutaneously via prefilled syringe or autoinjector
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
71
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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Antwerpen, Belgia, 2060
- SGS Belgium NV Research Unit Stuivenberg
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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
Mann
Beskrivelse
Inclusion criteria:
- Healthy male, non-athletic* Caucasian subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure [BP], pulse rate [PR]), 12-lead ECG, and clinical laboratory tests.
- Age between 18 and 65 years (inclusive)
- BMI of 18 to 30 kg/m2 (inclusive)
- BMI 18 to <20, or
- BMI 20 to <25, or
- BMI 25 to <=30
- Signed and dated written informed consent prior to admission to the trial in accordance with Good Clinical Practice (GCP) and local legislation.
Subjects agree to use an acceptable method of contraception during the trial and for 6 month after the dose of trial drug.
- Non-athletic defined as person performing no more than one hour of exercise per week
Exclusion criteria:
- Any finding in the medical examination (including BP, PR or ECG) that deviates from normal and judged as clinically relevant by the investigator.
- Any evidence of a concomitant disease judged as clinically relevant by the investigator including gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders or diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders.
- History of relevant orthostatic hypotension, fainting spells, or blackouts.
- Chronic or relevant acute infections.
- Positive result for HIV, HBV, and hepatitis C (Hep C) at screening.
- History of relevant allergy or hypersensitivity including allergy to the trial medication, its excipients or device materials (e.g. natural rubber or latex).
- Intake of drugs with a long half-life (more than 24 hours) within 30 days or less than 5 half-lives of the respective drug prior to administration of trial medication.
- Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial.
- Previous exposure to a biologic drug.
- Intake of an investigational drug in another trial within 2 months prior to intake of trial medication in this trial or intake of an investigational drug during the course of this trial.
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day).
- Inability to refrain from smoking during days of confinement at the trial site.
- Alcohol abuse (consumption of more than 4 units/day).
- Unwillingness/inability to refrain from intake of alcoholic beverages from 48 hours prior to the trial medication administration and until Day 14 post trial medication administration; and/or to limit alcohol intake to a maximum of 3 units per day until e.o.t.
- Drug abuse or positive drug screening.
- Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial.
- Intention to perform excessive physical activities within 1 week prior to administration of trial medication or contact sport during the entire trial and unwilling to avoid vigorous exercise for 14 days post dosing.
- Inability to comply with dietary regimen of trial site.
- Any out-of-range laboratory values considered clinically significant by the investigator; subjects with creatine kinase (CK) values 2 times the upper limit of normal (ULN) at Day -1 are excluded from participation.
- Subject is assessed as unsuitable for inclusion by the investigator, for instance, because he is considered not able to understand and comply with trial requirements, or has a condition that would not allow safe participation in the trial.
- Subjects with any immunological disorders or auto-immune disorders, (e.g., RA, lupus erythematosus, scleroderma, etc.).
- Subject has received a live vaccine within 12 weeks prior to enrolling in the trial.
- History of TB or positive finding in IGRA.
- Evidence of skin irritation or infection at the planned injection place.
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: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: BI 695501 prefilled syringe
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Eksperimentell: BI 695501 autoinjector
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Maximum Measured Concentration of BI 695501 in Plasma (Cmax)
Tidsramme: PK plasma samples were taken at: 1 hour (h) before drug administration and 1h, 4h, 8h,12h, 24h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, 132h, 144h, 168h, 216h, 336h, 504h, 672h, 840h, 1008h after drug administration.
|
Maximum measured concentration of BI 695501 in plasma (Cmax).
The rate and extent of absorption of BI 695501 by assessment of maximum plasma concentration following administration via AI or via PFS of a single dose of 40 mg BI 695501.
During analysis, it was realized that the PK sample on Day 43 had originally been mistakenly associated with a 1032 h time point, rather than with 1008 h.
However, PK parameters are calculated using actual values so this did not impact the analysis results.
|
PK plasma samples were taken at: 1 hour (h) before drug administration and 1h, 4h, 8h,12h, 24h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, 132h, 144h, 168h, 216h, 336h, 504h, 672h, 840h, 1008h after drug administration.
|
Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 to 1032 Hours After Dose (AUC0-1032)
Tidsramme: PK plasma samples were taken at: 1 hour (h) before drug administration and 1h, 4h, 8h,12h, 24h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, 132h, 144h, 168h, 216h, 336h, 504h, 672h, 840h, 1008h after drug administration.
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Area under the concentration-time curve of the BI 695501 in plasma over the time interval from 0 to 1032 hours after dose (AUC0-1032).
The rate and extent of absorption of BI 695501 by assessment of AUC0-1032 following administration via AI or via PFS of a single dose of 40 mg BI 695501.
During analysis, it was realized that the PK sample on Day 43 had originally been mistakenly associated with a 1032 h time point, rather than with 1008 h.
However, PK parameters are calculated using actual values so this did not impact the analysis results.
|
PK plasma samples were taken at: 1 hour (h) before drug administration and 1h, 4h, 8h,12h, 24h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, 132h, 144h, 168h, 216h, 336h, 504h, 672h, 840h, 1008h after drug administration.
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Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)
Tidsramme: PK plasma samples were taken at: 1 hour (h) before drug administration and 1h, 4h, 8h,12h, 24h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, 132h, 144h, 168h, 216h, 336h, 504h, 672h, 840h, 1008h after drug administration.
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Area under the concentration-time curve of the BI 695501 in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) based on observed concentration at time of last measurable concentration.
The rate and extent of absorption of BI 695501 by assessment of (AUC0-∞) following administration via AI or via PFS of a single dose of 40 mg BI 695501.
During analysis, it was realized that the PK sample on Day 43 had originally been mistakenly associated with a 1032 h time point, rather than with 1008 h.
However, PK parameters are calculated using actual values so this did not impact the analysis results.
|
PK plasma samples were taken at: 1 hour (h) before drug administration and 1h, 4h, 8h,12h, 24h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, 132h, 144h, 168h, 216h, 336h, 504h, 672h, 840h, 1008h after drug administration.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Subjects With Drug-related Adverse Events (AEs)
Tidsramme: From the first drug administration until 43 days observation period after drug administration and up to 70 days safety follow up period
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Number of subjects with drug-related Adverse Events (AEs).
Any event with an onset after the administration of the trial medication up to a period of 70 days was defined as a treatment-emergent AE (TEAE).
A treatment-related AE was defined as any TEAE assessed by the investigator as related to the trial medication.
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From the first drug administration until 43 days observation period after drug administration and up to 70 days safety follow up period
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Samarbeidspartnere og etterforskere
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Sponsor
Publikasjoner og nyttige lenker
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Hjelpsomme linker
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)
28. oktober 2015
Primær fullføring (Faktiske)
7. september 2016
Studiet fullført (Faktiske)
4. oktober 2016
Datoer for studieregistrering
Først innsendt
16. november 2015
Først innsendt som oppfylte QC-kriteriene
16. november 2015
Først lagt ut (Anslag)
17. november 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. desember 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. juni 2018
Sist bekreftet
1. juni 2018
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 1297.6
- 2015-003029-32 (EudraCT-nummer)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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