CompletedPhase 2

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Administering Multiple Oral Doses of GSK1292263 Alone and With Atorvastatin

United States287 participantsStarted 2010-09-14

Plain-language summary

This study investigates the safety, pharmacokinetics and effects of GSK1292263 when taken alone or when co-dosed with atorvastatin to subjects with dyslipidemia.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy adult males and females of non-child-bearing-potential, aged 18-75 years who is capable of giving informed consent. * A female subject is eligible to participate if she is of: * Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. In questionable cases, a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 MlU/ml and estradiol \<40 pg/ml (\<140 pmol/L) is confirmatory in the absence of a clear post-menopausal history. * Females on hormone replacement therapy (HRT) must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study. * Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until seven days following the last dose. * Body weight \> 50 kg (110 pounds) and body mass index (BMI) between 19.0 and 39.0 (inclusive). * Part A: (i) Subjects who are on 80mg or 40mg atorvastatin for \>= 4 weeks and are tolerating the drug well, or (ii) Subjects not on lipid-modifying therapy who have a fasting low…

What they're measuring

Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)- Part A

Timeframe: Up to Day 26

Number of Participants With Any AEs and SAEs- Part B (Washout)

Timeframe: Up to Day 28

Number of Participants With Any AEs and SAEs- Part B (Run-in)

Timeframe: Up to Day 28

Number of Participants With Any AEs and SAEs- Part B (Pooled Treatment Arm)

Timeframe: Up to Day 26

Number of Participants With Abnormal- Clinically Significant Electrocardiogram (ECG) Findings- Part A

Timeframe: Up to Day 26

Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Washout)

Timeframe: Up to Day 28

Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Run-in)

Timeframe: Day 28

Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Pooled Treatment Arm)

Trial details

NCT IDNCT01218204

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-06-29

Results submitted2017-08-31

View on ClinicalTrials.gov More Dyslipidaemias trials

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)- Part A

Timeframe: Up to Day 26

Number of Participants With Any AEs and SAEs- Part B (Washout)

Timeframe: Up to Day 28

Number of Participants With Any AEs and SAEs- Part B (Run-in)

Timeframe: Up to Day 28

Number of Participants With Any AEs and SAEs- Part B (Pooled Treatment Arm)

Timeframe: Up to Day 26

Number of Participants With Abnormal- Clinically Significant Electrocardiogram (ECG) Findings- Part A

Timeframe: Up to Day 26

Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Washout)

Timeframe: Up to Day 28

Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Run-in)

Timeframe: Day 28

Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Pooled Treatment Arm)