A Drug-drug Interaction Study to Investigate the Effects of AZD1981 on the Metabolism and Pharmacodynamics of Oral Contraceptives

NCT01110525 — Phase 1, Completed, 28 participants, AstraZeneca

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A Phase I, Double-blind, Randomised, Placebo-controlled, Two-cycle Crossover, Drug-drug Interaction Study to Investigate the Effects of AZD1981 Tablets 400 mg Twice Daily on the PK and PD of Oral Contraceptives in Healthy Female Volunteers

Registry	NCT01110525
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: double, basic science
Enrollment	28 (Estimated)
Sponsor	AstraZeneca (Industry)
Conditions	Oral Contraceptives
Interventions	AZD1981, Neovletta 21/28, Placebo AZD1981 (Drug)
Dates	start 2010-05-01, primary completion 2010-10-01, completion 2010-10-01, first posted 2010-04-26, last updated 2010-11-18
Locations	2 sites in Sweden

-Summary

The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the metabolism of hormones included in oral contraceptives.

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+Arms and interventions

Arm	Type	Interventions	Description
1	Experimental	Drug: AZD1981; Drug: Neovletta 21/28	AZD1981 + Oral contraceptive
2	Placebo comparator	Drug: Neovletta 21/28; Drug: Placebo AZD1981	Placebo + Oral contraceptive

AZD1981 (Drug): 4X100 mg per oral, twice daily for 28 days
Neovletta 21/28 (Drug): Once daily with (21) or without (28) pause for bleeding.
Placebo AZD1981 (Drug): 4X100 mg per oral, twice daily for 28 days

+Outcome measures

Primary outcomes

Pharmacokinetics of of EE and LNG by analysis of the AUC and Css,max. [PK sampling will be performed regularly during the study period of two months.]

Secondary outcomes

Effect on LH, FSH, SHBG, progesterone, and E2 during the menstrual cycle: Serum concentrations of LH, FSH, SHBG, progesterone and E2 [PD sampling will be done at the end of treatment period 1 and 2.]
Safety and tolerability of the combination: Adverse events, safety laboratory variables, pulse, blood pressure, electrocardiogram and physical examinations [Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study.]
Steady state PK of 1981 in combo with oral contraceptives AUCτ, Css,max, time to Cmax during a dosing interval (tmax ss);apparent plasma clearance (CLss/F) of AZD1981(tmax ss) of EE and LNG; Morning Ctrough values of EE and LNG will be measured. [PK-sampling of AZD1981 wil be done at the end of treatment period 1 and 2.]

+Eligibility

Sex: Female, ages: 18 Years to 45 Years, accepts healthy volunteers

Inclusion Criteria:

* Females of childbearing potential
* Use of Neovletta or Neovletta 28 minimum 3 months prior to enrolment.
* Willing to use a highly effective method of birth control, ie, double barrier method contraception.

Exclusion Criteria:

* Pregnancy and/or lactation or delivery/abortion within 6 months prior to randomisation.
* Any clinically significant disease or disorder.
* Any clinically relevant abnormal findings in physical examination.

+Locations (2)

Facility	City	Country	Status
Research Site	Luleå	Sweden
Research Site	Uppsala	Sweden

+Investigators

Eva S Pettersson, Study director, AstraZeneca R&D
Wolfgang Kühn, Principal investigator, Quintiles AB, Phase I Services
Aslak Rautio, Principal investigator, Quintiles Hermelinen AB