A study to compare low-volume blood sampling techniques versus conventional blood collection from veins to evaluate drug concentration profiles after administration of a single dose of various study drugs in healthy subjects

Phase 1

• Conditions: Blood sampling techniques; Not Applicable

• Registration Number: ISRCTN10792815
• Lead Sponsor: Roche (United States)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-12
• Last Update Posted: 24 January 2022
• Study Completion: 2022-05-19

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Body mass index 18-32 kg/m2
2. Body weight 45-120 kg
3. Good health, as demonstrated by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs
4. Clinical laboratory evaluations (including chemistry panel [fasted at least 8 hours], CBC, coagulation testing [PT, INR, aPTT, and fibrinogen], and urinalysis [see Appendix 5]) within the reference range for the respective test laboratory, unless deemed not clinically significant by the investigator
5. Negative test for selected drugs of abuse at screening (does not include alcohol) and at check-in (Day -1) (does include alcohol)
6. Negative hepatitis panel (including hepatitis B surface antigen, hepatitis B virus core antibody, and hepatitis C virus antibody) and negative human immunodeficiency virus (HIV) antibody screens
7. Negative screening test for latent mycobacterium tuberculosis (TB) infection by QuantiFERON® TB Gold
Indeterminate results may be confirmed by repeat test or by a purified protein derivative (PPD) skin test
8. Agreement to refrain from strenuous exercise from 48 hours prior to check-in (Day -1) and during the study duration
9. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs
10. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Exclusion Criteria

1. Pregnancy or breastfeeding, or intention to become pregnant during the study or within the following time windows after the dose of study treatment:
1.1. 8 weeks after the dose of crenezumab
1.2. 24 weeks after the dose of etrolizumab
1.3. 9 days after the dose of giredestrant
1.4. 29 weeks after the dose of hydroxychloroquine
2. Significant history or clinical manifestation of any metabolic, immunologic, allergic, dermatological, hepatic, renal, hematological, pulmonary, respiratory, cardiovascular, gastrointestinal, neurological, or psychiatric disorder, acute infection, or other unstable medical disease (as determined by the Investigator)
3. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator
4. History or presence of an abnormal ECG that, in the Investigator’s opinion, is clinically significant
5. QTcF interval of > 450 ms for males or > 470 ms for females; PR interval of > 210 ms; or QRS complex of >120 ms
6. History of alcoholism or drug addiction within 6 months prior to check-in (Day -1) that, in the judgment of the Investigator, may put the subject at risk for being unable to participate for the full duration of the study
7. History of malignancy, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or completely excised basal cell or squamous cell carcinoma of the skin
8. History of active or latent TB, regardless of treatment history
9. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days (whichever is longer) prior to check-in (Day -1)
10. Receipt of any prescription medications/products within 14 days prior to check-in (Day -1), unless deemed acceptable by the investigator
11. Receipt of any new over-the-counter (OTC), non-prescription preparations (including vitamins; minerals; and phytotherapeutic-, herbal-, and plant-derived preparations) within 7 days prior to check-in (Day -1), unless deemed acceptable by the Investigator
12. Consumption of alcohol-containing foods or beverages within 72 hours prior to check-in (Day -1), unless deemed acceptable by the Investigator
13. Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to check-in (Day -1)
14. Donation of blood within 30 days prior to screening or plasma within 2 weeks prior to screening
15. Receipt of blood products within 2 months prior to check-in (Day -1)
16. Poor peripheral venous access
17. Any acute or chronic condition that, in the investigator’s judgment, would limit the subject’s ability to complete and/or participate in this clinical study

Study & Design

• Study Type: Interventional
• Study Design: Not specified