A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Doses of Mipomersen in Japanese Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
Isis Pharmaceuticals
Information provided by (Responsible Party):
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT01299298
First received: February 9, 2011
Last updated: April 13, 2012
Last verified: April 2012

February 9, 2011
April 13, 2012
January 2011
April 2011   (final data collection date for primary outcome measure)
  • Maximum plasma concentration (Cmax) [ Time Frame: Baseline up to Day 36 Post-Treatment ] [ Designated as safety issue: No ]
    plasma PK parameters
  • Time to maximal concentration (Tmax) [ Time Frame: Baseline up to Day 36 Post-Treatment ] [ Designated as safety issue: No ]
    plasma PK parameters
  • Area Under the Curve (AUC) [ Time Frame: Baseline up to Day 36 Post-Treatment ] [ Designated as safety issue: No ]
    plasma PK parameters
Same as current
Complete list of historical versions of study NCT01299298 on ClinicalTrials.gov Archive Site
Number of Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Day 36 Post-Treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Doses of Mipomersen in Japanese Healthy Volunteers
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Doses of Mipomersen Administered Subcutaneously to Japanese Healthy Subjects

This Phase 1 study is being conducted to evaluate 3 increasing subcutaneous (SC) doses (50, mg, 100 mg or 200mg) of mipomersen in Japanese healthy volunteers. Eligible subjects will receive a single study injection of either mipomersen or placebo. Subjects will be enrolled into 1 of 3 treatment cohorts (Cohorts A, B, and C) in a dose-escalation design. Dose-escalation will proceed only if there is an acceptable safety profile from the previous dosing level.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy Volunteer
  • Drug: mipomersen
    50 mg (cohort A), 100mg (cohort B) or 200mg (cohort C) subcutaneous (SC) single dose of study drug
    Other Name: ISIS 301012
  • Drug: placebo
    50 mg (cohort A), 100mg (cohort B), or 200mg (cohort C) subcutaneous (SC) single dose of study drug
  • Experimental: mipomersen
    50 mg (cohort A), 100mg (cohort B) or 200mg (cohort C) SC single dose
    Intervention: Drug: mipomersen
  • Placebo Comparator: placebo
    50 mg (cohort A), 100mg (cohort B) or 200mg (cohort C) SC single dose
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • First generation Japanese (born in Japan of Japanese parents and Japanese grandparents), lived no more than 5 years outside of Japan, with no significant change in lifestyle or habits, including diet, while living outside of Japan.
  • Surgically sterile, abstinent or subject or partner compliant with acceptable contraceptive during and 24 weeks after the last study drug dose
  • Body weight >50 kg and body mass index between 18 and 30 kg/m2 inclusive

Exclusion Criteria:

  • Clinically significant cardiovascular, pulmonary, hepatic, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, infectious, or psychiatric disease
  • Clinically significant abnormal findings on the physical examination, ECG, blood pressure, heart rate, medical history, or clinical laboratory results at Screening or before dosing
  • Positive test for human immunodeficiency virus (HIV), hepatitis B or C.
  • High sensitivity C-reactive protein (hsCRP) >5 mg/L
  • History of or current malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for > 1 year)
  • Evidence of acute or ongoing chronic inflammatory condition or infection
  • History of rash, impetigo, or drug allergies
  • Alcohol and/or drug abuse
  • Smoking more than 10 cigarettes per day
  • Planned dental work up to and including Day 8 procedures
  • Treatment with another investigational drug, biological agent, or device within 4 weeks of Screening or 5 half-lives of the study agent, whichever is longer
  • Use of prescribed medications within 4 weeks or over-the counter medications (including dietary supplements and herbal remedies) within 14 days before the first study drug dose, or use of any concomitant medications (prescribed or over the counter) through Day 8 of the study without Investigator and Sponsor approval. Vaccinations are not allowed beginning 3 weeks prior to the first dose of study drug until completion of the safety follow-up period
  • Previous exposure to oligonucleotide-based drug therapy
  • Donated 50 to 499 mL of blood within 30 days prior to consent, or >499 mL within 60 days
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01299298
MIPO3700710, 2010-021948-18
Yes
Genzyme, a Sanofi Company
Genzyme, a Sanofi Company
Isis Pharmaceuticals
Study Director: Medical Monitor Genzyme, a Sanofi Company
Genzyme, a Sanofi Company
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP